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NEWS -- CytoSorb® Becomes a Featured Blood Purification Therapy on Fresenius Medical Care Critical Care Platforms
BAD HOMBURG V.D. HÖHE, GERMANY and PRINCETON, N.J., Aug. 2, 2022 /PRNewswire/ -- Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME) and CytoSorbents Corporation (NASDAQ: CTSO) have expanded their partnership by establishing a multi-stage global collaboration to combat life-threatening diseases in critical care for an initial term of three years. The new agreement provides for the combined marketing and promotion of CytoSorb® with Fresenius Medical Care's critical care products by Fresenius Medical Care's marketing organization worldwide, excluding the United States. Compared to the prior co-marketing agreement, this agreement increases the commitments from both parties and ensures an ongoing and consistent level of marketing and promotional activity specifically focused around CytoSorb, where Fresenius Medical Care will actively market and promote CytoSorb as the featured blood purification therapy for removal of cytokines, bilirubin, and myoglobin on its critical care platforms. Over the next three years, various Fresenius Medical Care-led in-person, virtual, social media, and web-based marketing programs and events will feature CytoSorb therapy and highlight the cooperation between the two companies in the field of critical care.
Fresenius Medical Care and CytoSorbents expand global marketing collaboration featuring CytoSorb
"As part of Fresenius Medical Care's commitment to providing our customers with leading solutions for their critical care patients, we are pleased to announce this new global collaboration with CytoSorbents," said Dr. Olaf Schermeier, CEO of Critical Care at Fresenius Medical Care. "With the ability to seamlessly integrate CytoSorb with our multiFiltratePRO acute dialysis platform that is routinely used throughout the world today, we have the opportunity to positively impact patient care for various life-threatening conditions such as sepsis, liver failure, trauma, lung injury, and many others."
Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents commented, "CytoSorb adds a powerful new dimension of blood purification to Fresenius Medical Care's critical care portfolio. It is specifically designed to reduce toxic levels of cytokines, bilirubin, and myoglobin that can lead to organ failure. The process is similar to hemodialysis, mastered by Fresenius Medical Care to treat kidney failure, which removes accumulated small to medium-sized, water-soluble molecules and toxins from the bloodstream. However, CytoSorb adds the ability to remove large molecules and toxins that are poorly removed by hemodialysis. Combined, the two therapies work together in a complementary manner to provide treatment for a broad range of conditions in the intensive care unit."
Dr. Steiner went on to highlight the importance of this collaboration stating, "Together with Fresenius Medical Care, we now have the ability to broadly and consistently communicate the benefits of CytoSorb therapy to customers throughout the world. In addition, it enables us to execute targeted marketing campaigns in collaboration with Fresenius Medical Care which will help to accelerate the introduction and adoption of CytoSorb. Overall, I believe this will be the starting point for further exciting developments on both the medical and business fronts."
Mr. Chris Cramer, Vice President of Business Development at CytoSorbents commented, "We are excited to expand our relationship with our long-standing partner, Fresenius Medical Care. This agreement promotes a stronger collaboration with Fresenius Medical Care's global commercial organization to more effectively bring our CytoSorb therapy to more customers around the world as a featured blood purification solution on Fresenius Medical Care's critical care platforms. We believe the synergy has the potential to create sustained and broader growth for both companies over time and is just the first of multiple opportunities to offer our combined critical care solutions."
In addition to strengthening and expanding the global marketing of CytoSorb, CytoSorbents and Fresenius Medical Care also plan to work together to bring new innovative solutions to the market. The agreement also includes the certification of compatibility between CytoSorb and Fresenius Medical Care's current critical care platforms. To help support the increased marketing and promotional efforts of the expanded collaboration, CytoSorbents has agreed to subsidize a portion of the marketing costs through a royalty payment to Fresenius Medical Care based on CytoSorb sales in the intensive care unit on Fresenius Medical Care platforms, excluding the United States.
About Fresenius Medical Care (NYSE: FMS; Frankfurt Stock Exchange: FME)
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.8 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,163 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approximately 346,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the Company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $39.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC) and others. The company has numerous marketed and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others. For more information, please visit the company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-looking statements
This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management's current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
Contacts Fresenius Medical Care AG & Co. KGaA
Investor Relations:
Else-Kröner-Straße 1
61346 Bad Homburg
Germany
+49 (0) 6172 609-0
mailto://ir@fmc-ag.com
Contacts CytoSorbents Corp.
Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@cytosorbents.com
Public Relations Europe:
Marcus Schult
kommponisten
+49 69 13823 ext. 960
+49 172 4238938
mailto://marcus.schult@die-kommponisten.com
CytoSorbents Europe GmbH:
Josephine Kraus
PA by Dr. Christian Steiner
+49 30 765 84 66 23
mailto://josephine.kraus@cytosorbents.com
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SOURCE CytoSorbents Corporation; Fresenius Medical Care
CytoSorbents Reports Second Quarter 2022 Financial and Operational Results
PRINCETON, N.J., Aug. 2, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended June 30, 2022.
Second Quarter 2022 Financial Results
Total Q2 2022 revenue, including product sales and grant income, was $8.5 million versus $12.0 million in Q2 2021, a decrease of 29%
Q2 2022 product sales were $7.3 million (negligible COVID-related sales) versus $11.4 million (includes $1.7 million in COVID-related sales) in Q2 2021. The decrease in the average Euro to U.S. dollar exchange rate lowered Q2 2022 product sales by approximately $840,000. On a constant currency basis, Q2 2022 core non-COVID sales would have been approximately $8.2 million, which represents a 15% decrease from approximately $9.7 million in core non-COVID sales a year ago, but comparable to the average currency adjusted core non-COVID sales over the prior three quarters
As expected, COVID-19 related sales during the quarter were negligible reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination and natural immunity
Product gross margins were approximately 67% in Q2 2022, versus 82% in Q2 2021. The decrease in the gross margin percentage was due primarily to manufacturing inefficiencies from a scheduled 4-week production hiatus as we relocated to our new production facility during the quarter
The Company maintains a healthy balance sheet with cash and cash equivalents of $31.9 million (which includes $1.7 million in restricted cash) as of June 30, 2022, and no debt
Recent Operating Highlights:
More than 179,000 cumulative CytoSorb devices have been utilized worldwide as of June 30, 2022, compared to more than 143,000 devices utilized cumulatively a year ago
Announced today the signing of an expanded global marketing agreement with Fresenius Medical Care where CytoSorb® will become a featured blood purification therapy on Fresenius Medical Care Critical Care platforms
Entered into a 3-year preferred supplier agreement with Asklepios Group, one of the largest private hospital operators in Germany
Partnered with Nikkiso to distribute the PureAdjust® hemoperfusion blood pump and supplies in a total of 14 countries, a key part of CytoSorbents' standalone device and machine strategy to expand the market for its products
Hosted the 2022 CytoSorb World Users' Meeting that highlighted the broad market potential of CytoSorb as an interdisciplinary therapeutic approach for a wide range of life-threatening illnesses
Multiple scientific papers were published on the positive use of CytoSorb in the areas of antithrombotic drug removal during acute aortic dissection and in vitro whole blood removal, Ex vivo lung perfusion for lung transplantation, Normothermic regional perfusion of Donation after Circulatory Death (DCD) human liver and kidney donors for organ transplant, Severe acute pancreatitis (PACIFIC study), Treatment of hyperbilirubinemia in acute liver dysfunction patients, A reduction in sepsis-associated mortality in left-sided acute infective endocarditis, and many others.
Relocated and established our Company headquarters and state of the art manufacturing facility in our new Princeton, New Jersey mixed-use facility
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Our second quarter core non-COVID product sales on a constant currency basis were $8.2 million and stable to the average currency adjusted core product sales for the prior three quarters. Although not the growth we are seeking, we achieved this despite continued softness in the German market, as the weakened healthcare system worked to recover from the massive COVID surge in the prior quarter and grappled with a myriad of problems. These include, for example, staffing shortages, budget issues, elective procedures restrictions, and a major 11-week hospital strike in western Germany that spanned a fifth of the population, postponing more than 10,000 operations and closing hospital wards. Year-over-year results were further impacted by a lack of COVID-19 related revenue due to a lessening in disease severity globally, and a drop of 12% in the Euro, to near parity with the U.S. dollar.
"Like most international companies, including those in the medical device and blood purification industries, we are dealing with not only fallout from the COVID pandemic, but also a storm of global macroeconomic and geopolitical uncertainty. That said, although our numbers do not yet reflect it, we are seeing some early but encouraging signs of improvement in key markets:
Continued strong and positive feedback from customers in both our direct and international territories, highlighted by the success of our recent in-person CytoSorb World User's meeting, with nearly 300 of the world's leading critical care physicians and research scientists from 40 countries participating
Marked improvement in sales representative access to hospitals in Germany, with 40% more sales visits during the quarter as compared to the prior quarter, though still down from pre-pandemic levels
Increasing levels of activity, interest, and in-person attendance of healthcare professionals at medical congresses in Europe and Latin America, and specific countries such as India, Spain, and Portugal
Strong pipeline of positive data being submitted and published by the international user community on CytoSorb use in a wide variety of areas
Though early, the Nikkiso expansion has triggered broad interest by customers in our stand-alone hemoperfusion pump offering, with initial placements, pump evaluations underway, and scheduled demonstrations at a number of hospitals
Growing synergy with our sales and medical affairs teams, and internal therapy area vertical leadership in critical care, cardiac surgery, and liver and kidney applications with a prioritization on sales support and clinical data
Recent preferred supplier agreement with Asklepios Group, one of the largest private hospital networks in Germany, making CytoSorb available without restrictions to all hospitals in the network
The potential for future sales acceleration, particularly in Germany, based upon the expansion of the Fresenius Medical Care global marketing partnership announced today, as further discussed below
Dr. Chan continued, "As we work to restore sales growth, we continue to advance our other key initiatives.
U.S. STAR-T and STAR-D clinical trials – These trials remain our top clinical priority with each trial now having a critical mass of more than 20 centers active and screening for enrollment. As we expand to 30 sites for each trial, recently approved by the FDA, the majority of our operational plans, resources, and focus have shifted from study start-up activities (Phase I) to activities driving enrollment (Phase II). For our lead study STAR-T, enrollment continues and we are targeting the first Data Safety Monitoring Board (DSMB) review at 40 patients enrolled, expected to be achieved with a slight delay in the next few months. STAR-D is underway also, with the rapid activation of trial sites
U.S. Manufacturing - Buildout of our new Princeton, NJ manufacturing facility is now complete with production of commercial devices split between our older production facility and our new facility, and final certification expected before the end of this year. Product gross margins dropped from 82% to 67%, driven mainly by production inefficiencies incurred by a scheduled 4- week production hiatus as we transitioned from our old to new manufacturing facilities, and lower sales volumes. We expect gross margins to return to previous levels as we complete the relocation to the new facility, eliminate the costs of the Monmouth Junction, NJ facility later this year, and begin to capture manufacturing efficiencies driven by an expected improvement in market conditions and increased product demand
Partnerships - Today we are pleased to announce an expanded global marketing agreement with long-time partner, Fresenius Medical Care ("Fresenius"), the world's leading provider of products and services for patients with renal diseases with headquarters and a strong sales and marketing footprint in Germany. Under the terms of the agreement, CytoSorb will become a featured blood purification therapy on Fresenius Medical Care's critical care blood purification platforms for the removal of cytokines, bilirubin, and myoglobin in critically ill patients, helping to expand the dimensions of blood purification beyond hemodialysis. Fresenius will be responsible for the specific worldwide marketing and combined promotion of CytoSorb with its critical care products across Fresenius-led in-person, virtual, social media, and web-based marketing programs and events during the term of the collaboration. In addition to strengthening and expanding the global marketing of CytoSorb, we plan to work together to bring new innovative solutions to the market. To help support the increased marketing and promotional efforts of the expanded collaboration, CytoSorbents has agreed to subsidize a portion of the marketing costs through a royalty payment to Fresenius Medical Care, with the royalty rate being based on certain assumptions regarding CytoSorb sales in the intensive care unit on Fresenius Medical Care platforms, excluding the United States, and subject to further adjustment should these assumptions change. Additional information can be found in the Form 8-K filed today.
Dr. Chan concluded, "We are excited about the many opportunities that we have to drive our business forward, but are proceeding conservatively, recognizing there is a seasonality to European business in general in the third quarter, driven by a lull in business activity as much of Europe takes vacation in July and August. Because of this, we are focused on executing our game plan, while controlling costs and conserving cash. We believe the high cash burn in Q2 2022 was an anomaly with a number of non-recurrent expenditures. These include, for example, the final $4.8 million payment related to the construction, capital equipment, and other costs of our new manufacturing facility (with the exception of approximately $300K in costs for the remainder of 2022), an approximate $1 million reduction in gross margin driven mainly by inefficiencies caused by scheduled production shutdowns associated with the relocation to our new manufacturing facilities, and lower sales volumes, and a $0.6 million increase in grant and accounts receivables during the quarter. Excluding these factors, our cash burn for Q2 2022 would have been approximately $6.5 million."
'In addition, we have $5 million (based on cost of goods) in working capital tied up in CytoSorb inventory that we have strategically built over several quarters to buffer against any potential disruption in production with the transition to the new facility. With fairly good visibility that the new manufacturing facility will come on-line as expected, we plan to release and monetize a portion of this inventory, which we expect could contribute an additional $1 million to our second half 2022 cash flow. Finally, we retain financial flexibility to add debt from our $15 million term loan with Bridge Bank if desired."
Results of Operations
Comparison for the three months ended June 30, 2022 and 2021:
Revenues:
Total revenue, including product revenue and grant income, for the second quarter of 2022 was $8.5 million, down 39% from $12.0 million in the second quarter of 2021. Revenue from product sales was approximately $7.3 million in the three months ended June 30, 2022, as compared to approximately $11.4 in the three months ended June 30, 2021, a decrease of approximately $4.0 million, or 36%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $0.8 million. For the three months ended June 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.06 as compared to an average exchange rate of $1.21 for the three months ended June 30, 2021. We estimate that demand for CytoSorb to treat COVID-19 patients was de minimis in the second quarter of 2022 as compared to approximately $1.7 million in the second quarter of 2021. Overall direct sales declined by approximately $3.4 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions. COVID-19 restrictions remain in place at many hospitals throughout Germany and these restrictions continue to limit our access to hospital personnel, particularly the physicians.
Cost of Revenues:
For the three months ended June 30, 2022 and 2021, cost of revenue was approximately $3.6 million and $2.7 million, respectively. Product gross margins were approximately 67% for the three months ended June 30, 2022 as compared to approximately 82% for the three months ended June 30, 2021. The decrease in the gross margin percentage in 2022 was due primarily to inefficiencies associated with relocation of our production activities to our new manufacturing facility during the second quarter of 2022.
Operating Expenses:
For the three months ended June 30, 2022, operating expenses were approximately $13.3 million, as compared to approximately $14.2 million for the three months ended June 30, 2021, a decrease of approximately $0.9 million or 6%. Selling, general and administrative (SG&A) expenses decreased approximately 14% to $8.4 million in the quarter from $9.8 million in the prior year. This decrease was due to a decrease in royalty expenses of approximately $0.4 million due to the decrease in product sales, a decrease in non-cash restricted stock expense of approximately $1.5 million related to restricted stock units granted to the Company's executive officers and a decrease in non-cash stock compensation expense of approximately $0.8 million. This was offset by increases in salaries, commissions, and related costs of approximately $0.2 million, an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.4 million, an increase in travel and entertainment costs of approximately $0.3 million and an increase in occupancy costs of approximately $0.4 million related to the rent expense on our new manufacturing facility. Research and development expenses increased by approximately $0.5 million primarily due to costs related to our STAR-T and STAR-D trials in the United States.
Gain (Loss) on Foreign Currency Transactions:
For the three months ended June 30, 2022, the loss on foreign currency transactions was approximately $2.5 million as compared to a gain of approximately $0.2 million for the three months ended June 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar at June 30, 2022 as compared to March 31, 2022. The spot exchange rate of the Euro to the U.S. dollar was $1.05 per Euro at June 30, 2022, as compared to $1.11 per Euro at March 31, 2022.
Comparison for the six months ended June 30, 2022 and 2021:
Revenues:
Total revenues were approximately $17.2 million for the six months ended June 30, 2022, as compared to total revenues of approximately $22.6 million for the six months ended June 30, 2021, a decrease of approximately $5.4 million, or 24%. Revenue from product sales was approximately $15.3 million in the six months ended June 30, 2022, as compared to approximately $21.5 million in the six months ended June 30, 2021, a decrease of approximately $6.2 million or 29%. The decrease in the average exchange rate of the Euro to the U.S. dollar negatively impacted 2022 product sales by approximately $1.4 million. For the six months ended June 30, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.09 as compared to an average exchange rate of $1.21 for the six months ended June 30, 2021. Though difficult to quantify, we estimate that approximately $0.3 million of total product sales in the six months ended June 30, 2022 was due to the demand for CytoSorb to treat COVID-19 patients as compared to $3.5 million in the six months ended June 30, 2021. Overall direct sales declined by of approximately $5.4 million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions. COVID-19 restrictions remain in place at many hospitals throughout Germany and these restrictions continue to limit our access to hospital personnel, particularly the physicians.
Cost of Revenues:
For the six months ended June 30, 2022 and 2021, cost of revenue was approximately $5.8 million and $5.5 million, respectively, an increase of approximately $0.3 million. Product gross margins were approximately 74% for the six months ended June 30, 2022 and approximately 79% for the six months ended June 30, 2021. The reduction in product gross margin is due primarily to inefficiencies associated with the relocation of our production activities to our new manufacturing facility during the second quarter of 2022.
Operating Expenses:
For the six months ended June 30, 2022, operating expenses were approximately $27.5 million as compared to approximately $24.9 million for the six months ended June 30, 2021, an increase of approximately $2.6 million, or 10%, for the six months ended June 30, 2022. Research and development expenses were approximately $8.4 million as compared to approximately $6.0 million for the six months ended June 30, 2021, an increase of approximately $2.4 million or 40%. This increase was due to an increase in costs associated with our STAR-T and STAR-D trials in the United States. Selling, general and administrative expenses were approximately $17.6 million for the six months ended June 30, 2022, as compared to $17.5 million for the six months ended June 30, 2021, an increase of $0.1 million. This increase is related to an increase in salaries, commissions and related costs of approximately $1.2 million, an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.7 million, an increase in travel and entertainment costs of approximately $0.5 million and an increase in occupancy costs of approximately $0.7 million related to the rent expense on our new manufacturing facility. These increases were offset by a decrease in royalty expenses of approximately $0.5 million, a decrease in non-cash restricted stock expense of approximately $1.7 million related to restricted stock units granted to the Company's executive officers, a decrease in non-cash stock compensation expense of approximately $0.7 million.
Gain (Loss) on Foreign Currency Transactions:
For the six months ended June 30, 2022, the loss on foreign currency transactions was approximately $3.7 million as compared to a loss of approximately $1.1 million for the six months ended June 30, 2021. The 2022 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2022 as compared to December 31, 2021. The spot exchange rate of the Euro to the U.S. dollar was $1.05 per Euro as of June 30, 2022, as compared to $1.14 per Euro at December 31, 2021.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of June 30, 2022, we had current assets of approximately $41.6 million including unrestricted cash on hand of approximately $30.2 million and current liabilities of approximately $10.6 million. As of June 30, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which is still available. In addition, we have $15 million of debt availability, providing financial flexibility, if needed. In April 2022, we received approximately $0.7 million in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.
We are also managing our resources proactively, continuing to invest in key areas such as our U.S. pivotal STAR-T and STAR-D trials. In April 2022, we began instituting tighter cost controls which are expected to reduce our planned cash burn by an additional $2 million per quarter. We are currently actively engaged in making further reductions to our operating costs to reduce our future cash burn.
We believe that we have sufficient cash to fund the Company's operations beyond twelve months from the issuance of these financial statements.
2022 Outlook Guidance
The macro environment in which we operate remains difficult to predict given the complex drivers of our business, the global nature of our operations, and external factors such as the COVID-19 pandemic, the Russia-Ukraine war, inflation, foreign currency exchange rate volatility, and other factors that are not under our direct control. Because of this, we expect that our business, and in particular product sales, may continue to see challenges for the remainder of 2022. However, we expect a gradual recovery of normalized hospital activity and sales access in Germany and other key countries in the coming quarters. With improved access and other growth initiatives, we expect a resumption of growth in our core non-COVID-19 product sales.
For additional information, please see the Company's Form 10-Q for the period ended June 30, 2022 filed on August 2, 2022 on http://www.sec.gov.
Conference Call
The Company will conduct its second quarter 2022 results call today at 4:30 p.m. Eastern time.
Conference Call Details:
Date: Tuesday, August 2, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
Live Presentation Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
An archived recording of the conference call will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 179,000 cumulative CytoSorb devices have been utilized as of June 30, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine or other macroeconomic factors, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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U.S. Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
avogel@cytosorbents.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
marcus.schult@die-kommponisten.com
SOURCE CytoSorbents Corporation
https://www.prnewswire.com/news-releases/cytosorbents-reports-second-quarter-2022-financial-and-operational-results-301598385.html
Comparison of the CytoSorb ® 300 mL and Jafron HA380 hemoadsorption devices: an in vitro study
Axel Nierhaus et al. Minim Invasive Ther Allied Technol. 2022.
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Minim Invasive Ther Allied Technol
. 2022 Aug 1;1-8.
doi: 10.1080/13645706.2022.2104617. Online ahead of print.
Authors
Axel Nierhaus 1 2 , Jesus Morales 3 , Daniel Wendt 3 4 , Jörg Scheier 3 , Dominik Gutzler 3 , Dominik Jarczak 1 2 , Frank Born 5 , Christian Hagl 5 , Efthymios Deliargyris 3 , Yatin Mehta 6
Affiliations
1 Clinic for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg, Hamburg, Germany.
2 Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
3 CytoSorbents, Princeton, NJ, USA.
4 Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, Essen, Germany.
5 Department of Cardiac Surgery, University Hospital, LMU Munich, Munich, Germany.
6 Medanta Institute of Critical Care and Anesthesiology, Gurgaon, India.
PMID: 35913784
DOI: 10.1080/13645706.2022.2104617
Cite
Abstract
Introduction: We performed an analysis of two blood purification systems to determine their performance for removing interleukins (ILs)-6 and 10, tumor necrosis factor (TNF)-a and monocyte chemoattractant protein (MCP)-1 from blood.
Material and methods: An in vitro hemoperfusion blood recirculation circuit was used to compare the CytoSorb® 300 mL (CytoSorbents Inc., Princeton, NJ) and Jafron HA 380 (Jafron Biomedical Co., Ltd., Zhuhai City, China) devices. The removal of purified recombinant human IL-6, IL-10, TNFa and MCP-1 by the adsorbers was compared at various timepoints. Three runs were completed and removal was evaluated as the mean area under the curve (AUC).
Results: Both devices showed effective removal of the tested cytokines. IL-6, IL-10, TNFa and MCP-1 were removed faster and to a higher extent by the CytoSorb® 300 mL device. At maximal time of 12 h, overall removal according to AUC of remaining concentrations was significantly lower with CytoSorb® 300 mL compared with HA 380 (IL-6: 1075.5 ± 665.9 vs. 4345.1 ± 1499.3 (p = 0.01), IL-10: 5065.7 ± 882.5 vs. 11,939.7 ± 4523.1 (p = 0.03), TNF-a: 6519.9 ± 997.6 vs. 10,303.7 ± 2347.0 (p = 0.03) and MCP-1: 278.9 ± 40.7 vs. 607.3 ± 84.4 (p = 0.001)).
Conclusions: Both the CytoSorb® and the Jafron HA 380 devices are capable of removing cytokines from blood in a benchtop model. The CytoSorb® 300 device was significantly more efficient achieving the bulk of the removal in the first 120 min.
Anyone know what this USPTO Patent hearing #2022-001867 is all about scheduled for this Tuesday @ 1pm in Virginia?
https://www.uspto.gov › filesPDF
AUGUST 2022 PTAB Public Hearing Schedule - USPTO
24 hours ago — CYTOSORBENTS CORPORATION. Tuesday, August 2, 2022. 1:00 PM (EDT). ALEXANDRIA, VA. B. 2022-002557. 15763920. RB HEALTH (US) LLC. Tuesday, August 2, 2022.
Literature Database
Reduction of primary graft dysfunction using cytokine adsorption during organ preservation and after lung transplantation
Ghaidan H, Stenli M, Niroomand A, Mittendorfer M, Hirdman G, Gvazava N, Edström D, Silva IAN, Broberg E, Hallgren O, Olm F, Wagner DE, Pierre L, Hyllén S, Lindstedt S. Nature Communications 2022; 13:4173
07/27/2022
New!Peer Reviewed Published DataSafetyTransplantImprov. resp functionAnimal modelsARDSExperimental setupInflammatory parameters
Link to source
Summary
Despite improvements, lung transplantation for end-stage disease remains hampered by both a scarcity of donor organs and by mortality following primary graft dysfunction (PGD). Since acute respiratory distress syndrome (ARDS) limits donor lung utilization, this study investigated the use of CytoSorb cytokine adsorption as a means of treating ARDS donor lungs. Ex-vivo lung perfusion (EVLP) was used to assess the donor lungs. Mild to moderate ARDS was induced via lipopolysaccharide (LPS) in 16 donor pigs. The non-treated group received EVLP and underwent transplantation without cytokine adsorption. The treated groups were subdivided between a ‘two step’ group (lungs were treated with CytoSorb both during EVLP (4 hours) and for 12 hours post transplantation) and a ‘one step’ group (use of CytoSorb only for 12 hrs postop). The primary endpoint of lung function was the PaO2/FiO2 ratio. Results showed that treatment with CytoSorb significantly decreased cytokine levels during EVLP and decreased levels of immune cells post-transplantation. Histology demonstrated fewer signs of lung injury across both treatment periods and the incidence of PGD was significantly reduced among treated animals. The effects of CytoSorb seemed to increase when used at two times points. In summary, CytoSorb cytokine adsorption in the context of ARDS injured lungs (i) reduced inflammation and restored pulmonary function during EVLP, (ii) restored pulmonary function and decreased inflammation following transplantation, and (iii) reduced the incidence of PGD in transplanted recipients. The authors suggest this treatment will increase the availability of donor lungs and increase the tolerability of donor lungs in the recipient.
YouTube video out, presentation from Cytosorbents conference on pig heart transplants etc.
Url -
Case of the Week
Literature Database
Use of CytoSorb hemoadsorption column during prolonged cardiopulmonary bypass in complex cardiac surgery patient
Marianne Alarie*, Maggie Savelberg, Danika Vautour and Igo B. Ribeiro | Kingston Health Sciences Centre, Kingston, ON, Canada | J Cardiothorac Surg 2022 Jul 7;17(1):172
07/27/2022
New!Peer Reviewed Published DataReduction in catecholaminesSafetyCardiac surgeryCase of the weekCase reportCPBIntra-Op
Download documentDownload documentLink to source
Summary
CoW 30/2022 – This case reports on a 61-year-old male, who was assessed by cardiac surgery in consideration for mitral valve surgery following presentation for congestive heart failure.
Summary
In this report a 61-year-old male with congestive heart failure was assessed for cardiac surgery, and was found to require mitral valve replacement, aortic valve replacement, tricuspid valve repair, single coronary artery bypass grafting and a left atrial appendage clip. Given the complexity of the surgery, the anticipated prolonged length of cardiopulmonary bypass, the associated risk of significant vasoplegia and his preoperative kidney dysfunction, the decision was made to integrate the CytoSorb cartridge into the cardiopulmonary bypass (CPB) circuit. One CytoSorb hemoadsorber was used intraoperatively throughout the CPB time (154 min). Despite an initial rise in vasopressor requirements, the mean arterial pressure (MAP) gradually improved during the time on by-pass whilst vasopressors could be weaned off completely. However, ten minutes post-bypass (i.e. after discontinuation of CytoSorb), the patient once again required multiple vasopressors to support his MAP. Despite the presence of postoperative thrombocytopenia, postoperative platelet counts did not significantly differ from baseline. Treatment was safe and feasible while integration into the cardiopulmonary bypass circuit was uncomplicated with no device-related complications. In this complex cardiac surgery patient, the authors state that the application of CytoSorb during cardiopulmonary bypass contributed to a decreased need for vasoactive support during and after surgery as well as improved postoperative outcomes, rendering it a promising therapeutic option in critically ill patients at risk of significant postoperative vasoplegia and multiorgan injury following prolonged and complex cardiac surgery.
Case presentation
Transthoracic echocardiography showed significant mitral valve calcification resulting in severe mitral regurgitation and moderate mitral stenosis. The right and left ventricles both had mild dysfunction with an ejection fraction of 46%. Further evaluation with transesophageal echocardiography revealed moderate aortic cusp calcification with moderate stenosis. Moderate tricuspid regurgitation was also noted. Coronary angiography revealed the presence of significant coronary artery disease with second diagonal ostial stenosis
The patient’s medical history included end-stage renal disease requiring intermittent hemodialysis, autoimmune cytopenia (severe thrombocytopenia, neutropenia) with mild responsiveness to preoperative steroids, New York Heart Association class III heart failure, hypertension, chronic obstructive pulmonary disease, severe untreated sleep apnea, previous Graves` disease diagnosis and atrial fibrillation
The patients’ preoperative blood work included a platelet count of 74?×?109/L, hemoglobin 91 g/L and hematocrit 29%. Preoperative creatinine was 598 µmol/L and glomerular filtration rate (GFR) was 8 mL/min/1.73 m2
The procedure included mitral valve replacement, aortic valve replacement, tricuspid valve repair, single coronary artery bypass grafting and left atrial appendage clip. Total cardiopulmonary bypass (CPB) time was 154 min, with a cross-clamp time of 115 min
Following induction of anesthesia and prior to commencement of the CPB, the patient required norepinephrine at 2 µg/min for hemodynamic support
A total of 3 units of packed red blood cells (pRBC), 2 units of platelets and 1 unit of prothrombin complex concentrate were administered to treat his perioperative anemia and coagulopathy
Given the complexity of the surgery (triple valve surgery), the anticipated prolonged length of cardiopulmonary bypass, the associated risk of significant vasoplegia and the preoperative kidney dysfunction, the decision was made to integrate the CytoSorb cartridge into the cardiopulmonary bypass circuit in this critically ill patient
Treatment
One CytoSorb hemoadsorber was used intraoperatively throughout the CPB time (154 min)
The CytoSorb device was inserted between the recirculation line (high-pressure line) and the venous reservoir of the CPB circuit. The cartridge was placed in a parallel fashion with the hemoconcentrator. The cartridge was primed and flushed with one liter of Ringer’s Lactate
Estimated blood flow rates through the CytoSorb: 200-230 mL/min
Anticoagulation: heparin with target activated clotting times (ACT) greater than 400 s, monitored every 20 to 30 min
Measurements
Hemodynamics and requirements for vasoactive substances
Total chest tube drainage volume
Ultrafiltration rate
Thrombocytes
Safety
Results
Following initiation of CPB and CytoSorb, norepinephrine infusion was increased to 5 µg/min for the first half hour of the bypass run under which the mean arterial pressure (MAP) could be sustained at around 45–50 mmHg. At the 40 min mark, MAP increased to a mean of 65–70 mmHg and the norepinephrine dose was reduced to 2 µg/min. After one hour on bypass, MAP increased to 70–75 mmHg and norepinephrine was discontinued. MAP levels above 60 mmHg were sustained for the remainder of the bypass run and there was no additional need for vasoactive support. Ten min post-bypass (i.e. after discontinuation of CytoSorb), the patient required dobutamine 5 µg/kg/min, norepinephrine 4 µg/min, epinephrine 5 µg/min and vasopressin 0.04 units/min for support. The patient was transferred to the cardiac intensive care unit on 5 µg/kg/min of dobutamine, 6 µg/min of norepinephrine, 5 µg/min of epinephrine and 0.04 units/min of vasopressin. Dobutamine was discontinued within the first postoperative hour. Vasopressin was stopped 24 h postoperatively. Norepinephrine was discontinued by the end of the 2nd postoperative day while epinephrine was eventually discontinued 48 h postoperatively
Total chest tube drainage was measured to be 1080 mL
Zero balance ultrafiltration was performed during bypass, with a total of 2.2 L of dialysate solution administered and 5.2 L of fluid removed via the hemoconcentrator
Postoperative platelet counts did not significantly differ from baseline
No adverse or any device-related side effects were documented during or after CytoSorb treatment
Patient Follow-up
Early postoperative blood work showed somewhat improved kidney function, with a creatinine of 394 umol/L and a GFR of 13 mL/min/1.73 m2
Lactate levels peaked at 3.4 mmol/L on the 6th postoperative hour and quickly normalized over the next 24 hours
Following the first postoperative day, the patient received an additional 3 units of pRBC, 2 units of fresh frozen plasma and 1 unit of platelets
Surgical drains were removed on the second postoperative day
The patient was extubated 48 h post-surgery
Hemodialysis treatments were resumed on the third postoperative day
The patient was transferred to the normal ward on the 6th postoperative day and discharged on the 11th postoperative day
Conclusion
In this complex cardiac surgery patient, application of CytoSorb during cardiopulmonary bypass contributed to a decreased need for vasoactive support during and after surgery as well as improved postoperative outcomes, rendering it a promising therapeutic option in critically ill patients at risk of significant postoperative vasoplegia and multiorgan injury following prolonged and complex cardiac surgery
The authors do not believe that CytoSorb therapy significantly impacted on the platelet concentrations or perioperative transfusion requirements
Treatment was safe and feasible while integration into the cardiopulmonary bypass circuit was uncomplicated with no device-related complications observed.
NEWS -- CytoSorbents to Report Second Quarter 2022 Operating and Financial Results
PRINCETON, N.J., July 25, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report second quarter 2022 operating and financial results after the market close on August 2nd, 2022. CytoSorbents' management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.
Conference call details:
Date: Tuesday, August 2, 2022
Time: 4:30 p.m. Eastern
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
The live audio webcast and presentation can be accessed via the following link: https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations portion of the company's website at https://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
U.S. Company Contact:
Amy Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
mailto://avogel@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-to-report-second-quarter-2022-operating-and-financial-results-301592192.html
SOURCE CytoSorbents Corporation
Case of the Week
Literature Database
Use of CytoSorb in a post kidney transplant pediatric patient with acute respiratory failure and sepsis
Dr. Rajiv Sinha | Paediatric Nephrology, Apollo Multispeciality Hospital, Kolkata, India
07/20/2022
New!PediatricsReduction in catecholaminesSafetySeptic ShockImprov. resp functionCase of the weekCase reportCritical CareIHD / SLEDInflammatory parameters
Download documentDownload document
Summary
CoW 29/2022 – This case reports on a 13-year-old girl from Bangladesh, who was admitted to the hospital with incipient renal failure and hypertension.
Case presentation
At the age of 9 months, she had been diagnosed with steroid resistant nephrotic syndrome secondary to WT1 mutation. She slowly progressed to end-stage renal disease and underwent bilateral nephrectomy and initiation of chronic peritoneal dialysis. Kidney transplantation was performed within 6 months (February, 2014), where the donor was the child’s mother. The patient was then on regular follow-ups in India until the current renal deterioration happened
On admission, the patient was found to have a creatinine of 2.5 mg/dl along with severe hypertension for which the patient was put on multiple anti-hypertensive drug therapy. A transplant renal biopsy was performed suggesting thrombotic microangiopathy. In view of her deteriorating renal function, the patient was prepared for renal replacement therapy (Perma-catheter insertion for hemodialysis)
Following admission, the patient’s condition deteriorated including epistaxis, dyspnoea, tachycardia, desaturation on room air and altered sensorium with increasing respiratory distress
Laboratory investigations revealed a leucocyte count of 13,700/µl, 91% neutrophils, platelets 0.85 lacs/cumm, C-reactive protein (CRP) 29.7mg/dl, INR of 4, aPTT of 120 secs, urea 142 mg/dl, and creatinine 4.1mg/dl
A subsequent chest X-ray showed patchy consolidations in the right perihilar region
She went on to develop hemodynamic instability with a drop in mean arterial pressure to 60 mmHg requiring initiation of vasopressor therapy (norepinephrine 0.8 µg/kg/min, epinephrine 0.5 µg/kg/min)
Additionally, the patient was intubated and put on mechanical ventilation with high ventilator settings including a positive end-expiratory pressure (PEEP) of 13 cmH2O, a peak inspiratory pressure (PIP) of 42 cmH2O, an FiO2 of 100% and a tidal volume of 5 ml/kg
Intravenous antibiotics were administered
Hemodialysis was initiated but had to be discontinued due to hypotension and the renal replacement therapy (RRT) modality was switched to Sustained Low Efficiency Dialysis (SLED)
As the patient was unresponsive to standard therapy and due to the ongoing clinical deterioration along with increased inflammatory markers (D-Dimer 2524.6 ng/ml, IL-6 5000 pg/ml), the decision was made to additionally integrate a CytoSorb hemoadsorber in order to control the hyperinflammatory response and to stabilize the patient hemodynamically
Treatment
One CytoSorb therapy session was performed for 8 hours on day 1
CytoSorb was used in conjunction with SLED therapy
Measurements
Hemodynamics and vasopressor requirements
Inflammatory markers
Ventilation invasiveness and oxygenation
Results
CytoSorb treatment resulted in a considerable improvement in the patient’s hemodynamic situation. 24 hours after initiation of therapy, norepinephrine had already decreased to 0.5 µg/kg/min and epinephrine to 0.1 µg/kg/min and continued to decrease also after cessation of CytoSorb therapy
Treatment with CytoSorb was further associated with a marked reduction in IL-6 (decrease from >5000 pg/ml to 44 pg/ml over the following 24 hours), indicating a clear control of the hyperinflammatory situation
Moreover, ventilation invasiveness decreased, and oxygenation improved
Patient Follow-up
RRT was continued for several consecutive days along with other supportive management
As the patient improved clinically, she was extubated on day 4 and kept on high flow oxygen therapy via nasal cannula
Antibiotic therapy was initiated for 14 days as the blood cultures were positive for Staphylococcus epidermidis(Coagulase-Negative Staphylococci)
The patient was finally discharged in a clinically stable condition with a follow-up plan for intermittent hemodialysis
Conclusion
In this case of a post kidney transplant pediatric patient with acute respiratory failure and sepsis, the use of CytoSorb hemoadsorption in combination with renal replacement therapy and standard therapeutic measures resulted in rapid hemodynamic stabilization, control of the hyperinflammatory response as well as improvement in ventilation invasiveness and oxygenation
Hemoadsorption therapy may therefore be a potentially important advance in the control of such conditions, if instituted early and judiciously. The presented case successfully adds to the growing experience from eastern India as the first case of pediatric hemoadsorption therapy
Use of CytoSorb in combination with SLED was safe and easy.
Hemoadsorption for severe MIS-C in critically ill children, should we consider it as a therapeutic opportunity?
Gabriella Bottari et al. Int J Artif Organs. 2022.
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Int J Artif Organs
. 2022 Jul 13;3913988221111179.
doi: 10.1177/03913988221111179. Online ahead of print.
Authors
Gabriella Bottari 1 , Flavia Severini 2 , Anna Hermine Markowich 2 , Giulia Lorenzetti 2 , Juan Carlos Ruiz Rodriguez 3 4 , Ricard Ferrer 3 4 , Paola Francalanci 5 , Antonio Ammirati 6 , Paolo Palma 7 , Corrado Cecchetti 1
Affiliations
1 Pediatric Intensive Care Unit, Pediatric Emergency Department, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
2 Department of Pediatrics, University of Rome Tor Vergata, Residency School of Pediatrics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
3 Intensive Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
4 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d'Hebron Research, Institute (VHIR), Barcelona, Spain.
5 Unit of Pathology, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
6 Pediatric Emergency Unit, Pediatric Emergency Department, Bambino Gesù Children's Hospital, IRCSS, Rome, Italy.
7 Clinical Immunology and Vaccinology Unit, Pediatric Academic Department (DPUO), Bambino Gesù Children's Hospital, IRCSS, Rome, Italy.
PMID: 35822878
DOI: 10.1177/03913988221111179
Cite
Abstract
Multisystem inflammatory syndrome (MIS-C) is a new severe clinical condition that has emerged during the COVID-19 pandemic. MIS-C affects children and the young usually after a mild or asymptomatic COVID-19 infection. MIS-C has a high tropism for the cardiovascular system with need for inotropes and vasopressor support in 62% of cases. As of today a mortality from 1.5% to 1.9% related to MIS-C is reported. Hemoadsorption via the inflammatory mediator adsorber CytoSorb (CytoSorbents Europe, Berlin Germany) has been used as adjunctive therapy with the aim to restore the host response in septic shock and other hyper-inflammatory syndromes. We present the clinical experience of an adolescent boy with a refractory shock secondary to left ventricular dysfunction (LVD) in the context of MIS-C, treated with hemoadsorption, and continuous kidney replacement therapy (CKRT) in combination with immunomodulatory therapies. The therapeutic strategy resulted in hemodynamic and clinical stabilization as well as control of the hyperinflammatory response. Treatment appeared to be safe and feasible. Our findings are in line with previously published clinical cases on Cytosorb use in MIS-C showing the beneficial role of the hemoperfusion with Cytosorb in severe MIS-C to manage the cytokine storm. We provide an analysis and comparison of recent evidence on the use of hemoadsorption as an adjuvant therapy in critically ill children with severe forms of MIS-C, suggesting this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygentation (ECMO) and other mechanical cardiocirculatory supports.
Keywords: Coronavirus; cytokines; left venticular failure (LVEF); multisystem inflammatory syndrome in children (MIS-C); myocarditis; pediatric critical care; shock.
Case of the Week 28
Literature Database
Use of CytoSorb in splenic abscessand septic shock due to intestinal ischemia following portal vein thrombosis and extensive small bowel resection
Dr. Klaus Kogelmann | Interdisciplinary Intensive Care Medicine, Emden Hospital, Germany
07/13/2022
New!Case of the week
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Summary
CoW 28/2022 – This case reports on a 37-year-old male patient with known type 1 diabetes mellitus, who was admitted to the hospital with nausea, multiple vomiting and abdominal pain.
Case presentation
The patient had already complained of nausea, vomiting, abdominal pain and multiple loose bowel movements about 10-12 days previously. After initial improvement after taking ibuprofen (1-2 times daily), the patient’s condition worsened again, leading to the current hospital admission
Initially, the patient presented with limited vigilance, tachycardia, tachypnoea, pale skin and cold sweats
On rectal digital examination pale blood was found
Additionally, sonography revealed dilated loops of the small intestine, which was clinically compatible with the diagnosis of peritonism
Consequently, there was an immediate indication for emergency surgery including median laparotomy, opening and draining of a splenic abscess found intraoperatively and application of a vacuum dressing to the open abdomen
Postoperatively, the patient was now in septic shock and transferred to the intensive care intubated and ventilated
Due to pronounced hemodynamic instability, a differentiated, protocol-based sepsis therapy (volume, catecholamines and calculated antibiotic therapy – with piperacillin/sulbactam as well as lung-protective ventilation) was started immediately
In addition, high-dose hydrocortisone administration (10 mg/h for 7 days) was initiated
On the following day and in the context of increasing intra-abdominal pressure and protracted septic shock, which was most likely due to the splenic abscess with consecutive portosplenomesenteric thrombosis and circulatory disturbances of the jejunum (mesenteric infarction), the patient underwent a re-operation and resection of the entire small intestine up to 10 cm from the oral and aboral ending, with creation of a jejunostoma and blind closure of the terminal ileum
Given a postoperative increase in catecholamine requirements (initial norepinephrine 0.22 µg/kg/min), infection markers (procalcitonin [PCT] 2 pg/ml, C-reactive protein [CRP] 145.9 mg/l), lactate levels (4.2 mmol/L), leukocytosis (42.5 thousand/µl) and anuria, combined continuous renal replacement therapy (CRRT) and adjunctive CytoSorb therapy were initiated with a CytoScore of 7 points
Behandlung
A total of 3 consecutive treatments with CytoSorb were performed over the following 3 days (each treatment for 24 hours)
CytoSorb was used in combination with CRRT (Multifiltrate, Fresenius Medical Care) run in continuous veno-venous hemodialylis (CVVHD) mode
Blood flow rate: 100 ml/min
Anticoagulation: Citrate
CytoSorb adsorber position: pre-hemofilter
Measurements
Hemodynamics and catecholamine requirements
Inflammatory parameters
Lactate
Results
Catecholamine therapy could already be discontinued after the 2nd treatment cycle
Treatment was further associated with a control of the hyperinflammatory response with clear reductions in inflammatory parameters (leukocytes 16.2/nl and PCT 0.47 pg/ml 24 h after the last treatment)
Lactate also returned to normal values (1.3 mmol/L) 24 h after the last treatment
Patient Follow-up
Discontinuation of dialysis and CytoSorb treatment on day 3
Invasive ventilation was also terminated after 3 days and the patient could be successfully extubated
Transfer from intensive care to the normal ward after a total of 7 days
Discharge from the hospital into his home environment after 21 days of total hospital stay
Currently the patient is permanently dependent on a daily parenteral fluid and nutrient supply. Thus, the patient appears to be a possible candidate for a small bowel transplant and has been referred to an appropriate centre
Conclusions
In this patient with septic shock, the combined treatment consisting of standard therapy, CytoSorb hemoadsorption and renal replacement therapy resulted in a marked stabilization in hemodynamics with rapid reduction of norepinephrine requirements as well as control of the hyperinflammatory situation
According to the authors, CytoSorb quickly and effectively helped to stabilize a critical condition
A CytoScore above 6 points represents a refractory shock state. The score may therefore help in the initiation of CytoSorb therapy
Treatment with CytoSorb was safe and feasible without technical problems.
Case of the Week 27
Literature Database
Use of CytoSorb hemoadsorption for the management of acute liver failure
Dr. Vinod Singh | Institute of Critical Care Medicine, Sir Gangaram Hospital, New Delhi, India
07/06/2022
New!Reduction in catecholaminesSafetyImprov. resp functionBilirubinCase of the weekCase reportCritical CareCRRT pre filterImprov. hep. encephalopathyLiver failure
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Summary
CoW 27/2022 – This case reports on a 28-year-old female patient who was referred intubated and ventilated from an intensive care unit (ICU) of another tertiary care hospital to Sir Gangaram Hospital, Delhi, with a confirmed diagnosis of acute liver failure with grade II hepatic encephalopathy and coagulopathy.
Case presentation
Before her initial admission to the peripheral hospital, the patient had a history of fever associated with chills and rigors for 7 days and was also suffering from abdominal pain. She also had a history of taking ayurvedic medicine for jaundice
Following hospitalization at the Sir Gangaram hospital, the patient’s vitals were recorded. Blood pressure and respiratory rate were 120/82 mmHg and 16/min, respectively
Subsequently, she was transferred to the intensive care unit (ICU) with impaired oxygenation and a PaO2/FiO2 ratio of 195 mmHg
Lab investigations showed a total leukocyte count of 13.9×103/µl as well as a platelet count of 67×103/µl. Coagulation tests revealed a grossly elevated International Normalized Ratio (INR) of 4.07
Her liver function tests were markedly abnormal (bilirubin 19.2 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) 164 U/L, serum glutamic-pyruvic transaminase (SGPT) 140 U/L) indicating pronounced and already established liver failure while she was also suffering from intermittent episodes of altered sensorium
Furthermore, she had elevated serum lactate levels (3.37 mmol/L)
However, serum creatinine level was normal at 1.19 mg/dl and urinary output was 4185 ml/day
The patient’s Glasgow Coma Scale (GCS) score was 6 while Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores were 13 and 12, respectively
Model for End-Stage Liver Disease (MELD) score was estimated to be 40
She also exhibited hemodynamic instability requiring norepinephrine support up to 3 µg/min
Abdominal ultrasound examination showed an enlarged liver and a contracted bladder with moderate free fluid in the peritoneal cavity, all signs suggestive of acute liver failure
The decision was made to perform 4 cycles of plasma exchange therapy
Given the patient’s critical condition and in order to accelerate liver toxin removal, but also to control the septic/hyperinflammatory condition, a CytoSorb hemoadsorption cartridge was additionally integrated into the plasma exchange therapy cycle
Rotational thromboelastometry (ROTEM) was used throughout the treatment interval to control for any changes in the coagulatory status. Accordingly, four units of fresh frozen plasma (FFP) and albumin had to be administered over this time
Measurements
Hemodynamics
Liver function
Lactate
Renal function
Respiratory parameters
GCS
SOFA score
Treatment
One CytoSorb therapy session was performed for a duration of 24 hours
The CytoSorb device was run in conjunction with plasma exchange therapy (Prismaflex, Baxter)
Blood flow rate: 150 ml/min
Anticoagulation: none
Results
Mean arterial pressure remained stable during CytoSorb therapy. Norepinephrine could be weaned off 2 hours after CytoSorb therapy completion
Treatment was associated with a rapid and sustained decline in bilirubin plasma levels with a concomitant decrease in liver transaminases
There also was a reduction in serum lactate under hemoadsorption treatment
Renal function improved as evidenced by an increase in urinary output
Lung function/oxygenation remained stable with a PaO2/FiO2 of 198 mmHg
GCS showed a slight improvement
SOFA score could be reduced
Parameters Before CytoSorb therapy After CytoSorb therapy
Mean arterial pressure (mmHg) 90 90
Bilirubin (mg/dL) 19.2 7.97
SGOT (U/L) 140 115
SGPT (U/L) 164 81
Serum lactate (mmol/L) 3.37 2.70
Urinary output (ml/day) 4185 4600
PaO2/FiO2 195 198
GCS Score 6 7
SOFA score 13 12
Patient Follow-Up
On suspecting autoimmune related acute liver failure the patient was put on steroids, and her acute kidney injury was managed conservatively. The patient was extubated as her condition improved and she was transferred to a high-dependency unit
Later, transjugular liver biopsy showed features of chronic venous hepatic congestion, and ultrasound doppler flow axis examination revealed hepatomegaly with bilateral mild pleural effusion and moderate ascites
As the steroids were not showing any effect on the patient’s condition, they were stopped. She was managed with IV antibiotics, anti-hepatic encephalopathy (HE) measures, diuretics, and other supportive measures
The patient’s family was informed about the need for liver transplantation based on above mentioned medical conditions
Patient was referred to a surgical gastroenterologist for evaluation of a liver transplant, and she decided to undergo cadaveric liver transplantation while simultaneously opting for discharge. Hence, she was discharged from hospital after 28 days of hospitalization in a stable condition and advised to follow-up with a liver clinic
Conclusions
In this case of a patient with acute liver failure, CytoSorb hemoadsorption in combination with plasma exchange and standard of care therapy resulted in a stabilization of her liver function including a rapid decrease in plasma bilirubin levels as well as a reduction in serum lactate levels and an overall improvement in the patient’s clinical condition
According to the authors, in this special case CytoSorb contributed towards controlling the hyperinflammation, and it also acted as an effective means of controlling the hyperbilirubinemia
CytoSorb in combination with plasma exchange therapy was safe and easy to apply.
NEWS -- The 2022 CytoSorb World Users' Meeting Highlights the Broad Market Potential of CytoSorb as an Interdisciplinary Therapeutic Approach
PRINCETON, N.J. and BERLIN, July 8, 2022 /PRNewswire/ -- During the recent 2022 CytoSorb Users' Meeting in Berlin, Germany hosted by CytoSorbents Corporation (NASDAQ: CTSO), leading critical care specialists, cardiac surgeons, and research scientists from around the world highlighted the use of CytoSorb® blood purification across a broad range of applications driven by major current trends in healthcare. Examples include diseases of the rapidly aging population such as sepsis and trauma, the high incidence and prevalence of chronic liver disease and acute liver failure, the growing global demand for solid organ transplants, the risk of bleeding caused by the widespread use of antithrombotic "blood thinning" medications, severe illness due to the COVID-19 pandemic, and many others.
CytoSorbents World Users' Meeting highlights expanding value of CytoSorb blood purification in critically ill patients
Nearly 300 specialists from 40 countries attended the conference in-person with leading KOLs presenting updates on the latest scientific findings, clinical study results, and data from new case series in an expansive agenda (seen here). These presentations underscore CytoSorb® as a pioneering, interdisciplinary therapeutic approach for organ support that both builds upon, and extends beyond, its first approved indication of cytokine reduction when launched in Europe ten years ago. Among the many notable speakers:
Is the wording "may be" and "may contribute" ever going to move the needle for us? "May"? I don't know how you get wide acceptance without at least being able to say to doctors "has been shown to"....something more positive(?) My cardiologist (I've survived 2 bouts of endocarditis and had radical aortic surgery) here in NJ practices out of Morristown Hospital, a heart surgery center, and told me he has never heard of CTSO or the filter. I recently wrote the company asking how this is possible with the co headquarters an hour away. In the same note I asked why Columbia Presbyterian in NYC says "withdrawn" on the trial. I think these are reasonable questions but they have never answered me. I'm not the only one not getting answers. Are we in a bunker mentality now?
Use of CytoSorb® hemoadsorption column during prolonged cardiopulmonary bypass in complex cardiac surgery patient
Marianne Alarie et al. J Cardiothorac Surg. 2022.
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J Cardiothorac Surg
. 2022 Jul 7;17(1):172.
doi: 10.1186/s13019-022-01922-7.
Authors
Marianne Alarie 1 , Maggie Savelberg 2 , Danika Vautour 2 , Igo B Ribeiro 2
Affiliations
1 Kingston Health Sciences Centre, Kingston, ON, Canada. marianne.alarie@kingstonhsc.ca.
2 Kingston Health Sciences Centre, Kingston, ON, Canada.
PMID: 35799205
DOI: 10.1186/s13019-022-01922-7
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Abstract
Background: Complex cardiac surgery and prolonged cardiopulmonary bypass are associated with significant activation of the systemic inflammatory response system. Pro-inflammatory cytokines, oxygen free radicals and complement activation products contribute to postoperative complications and multiorgan injury. CytoSorb® hemoadsorption therapy has been suggested to alleviate the hyperinflammatory response triggered by cardiopulmonary bypass during cardiac surgery.
Case presentation: We describe the use of CytoSorb® hemoadsorption therapy in a 61-year-old male presenting for aortic valve replacement, mitral valve replacement, tricuspid valve repair, coronary artery bypass grafting and left atrial appendage clip.
Conclusion: We were able to demonstrate that CytoSorb® use during cardiopulmonary bypass may be a safe and feasible adjunct therapy that may contribute to improved postoperative outcomes in a patient with complex cardiac disease.
Keywords: Bypass; Case report; CytoSorb; Cytokines; Hemoadsorption; Inflammation.
NEWS -- Leading Critical Care and Cardiac Surgery Specialists from 40 Countries Meet to Discuss CytoSorb and the New Dimension in Blood Purification
The 2022 CytoSorb World Users' Meeting focuses on groundbreaking new applications of the adsorption technology to celebrate the 10th anniversary of commercialization
PRINCETON, N.J. and BERLIN, July 1, 2022 /PRNewswire/ -- Under the theme "We Are Changing Medicine: CytoSorb Therapy - From the Past to the Future," CytoSorbents Corporation (NASDAQ: CTSO) is bringing together nearly 300 of the world's leading critical care physicians and renowned scientists, as well as some of the most experienced cardiovascular and liver specialists to the 2022 CytoSorb World Users' Meeting (WUM) on July 2, 2022 in Berlin, Germany. Together, they will discuss updates on the latest scientific findings, study results, and case series using CytoSorb blood purification in different clinical applications.
The kick-off and one of many highlights will be the keynote speech by Prof. Dr. Bruno Reichart, the cardiothoracic surgeon who performed the first successful human heart-lung transplant in Germany in 1983. He will discuss lessons learned from the renaissance of xenotransplantation – the transplantation of non-human organs into human patients – which could someday help to end the global shortage and waiting lists for donated organs. Solid organ transplant (e.g. hearts, lungs, kidneys, and livers) is an exciting new field for CytoSorbents. This includes multiple cardiothoracic surgery applications of CytoSorb during and after heart-lung transplants, and includes the burgeoning field of ex vivo organ perfusion with our E.U. approved ECOS-300CY®/PerSorb® cartridge, with the goal of rehabilitating solid organs to improve clinical outcomes.
In recent years, the WUM has established itself as an inclusive and highly-anticipated interdisciplinary event with pioneers and power users from all over the world exchanging first-hand insights into clinical results and experiences with CytoSorb in various fields of application. A major focus of this year's discussion by top-level participants will be the combination of CytoSorb and ECMO to treat lung failure, the use of CytoSorb to reverse septic shock, and how CytoSorb is helping to advance the treatment of acute liver failure.
"The dialogue and partnership with CytoSorb users over the past 10 years has proven immensely informative and personally rewarding," said Christian Steiner, EVP Marketing & Sales of CytoSorbents and Managing Director of CytoSorbents Europe. "The combined energy and ideas from this working group has led to some of the most exciting advances in the treatment of life-threatening illnesses using our CytoSorb therapy. Users have embraced the new dimension of blood purification that CytoSorb has enabled. One powerful example is the treatment of cytokine storm that is at the core of so many deadly conditions. On this important anniversary event, we can all be proud that we are 'Working to Save Lives'."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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SOURCE CytoSorbents Corporation
Literature Database
Sepsis Management in Southeast Asia: A Review and Clinical Experience
Mehta Y, Paul R, Rabbani R, Acharya SP, Withanaarachchi UK. Journal of Clinical Medicine 2022; 11(13);3635
06/27/2022
New!Peer Reviewed Published DataReviewSeptic Shock
Link to source
Summary
This review summarizes the literature that focuses on the diagnosis and treatment of sepsis, issues with colistin resistance, the increasing use of chloramphenicol, antibiotic abuse, resource constraints and finally the association of sepsis with COVID-19 in Southeast Asia. A panel of five experts discussed the literature and made the following recommendations:
Data on the incidence of sepsis in this region be collected and shared
The management of sepsis be personalized
Use of conventional approaches and innovative therapeutic alternatives to sepsis management be employed
In particular a personalized approach and innovative therapeutic alternatives such as CytoSorb are highlighted as potential options for the treatment of patients with sepsis in Southeast Asia. CytoSorb is described in detail, along with all the publications on these patients from this region. It is noted that it is now well established that absence of evidence is not evidence of absence. Therefore, adopting a personalized treatment approach wherever and whenever desirable and embracing novel extracorporeal blood purification technologies could further enhance patient outcomes and alleviate the burden of sepsis. In support of this, the authors state that instead of randomized control trials, that real-world evidence be used to show the benefit in determining the potential of CytoSorb for the management of sepsis.
Case of the Week
Literature Database
CytoSorb as adjuvant therapy in refractory ARDS and ECMO support in COVID-19
Dr. med. Martin Schmölz, Dr. med. T. Gröbl, Dr. med. A. Schirner, Dr. med. L. Wagner | Department for Anesthesiology, Intensive Care and Emergency Medicine, Immenstadt Clinic - Klinikverbund Allgäu gGmbH, Germany
06/29/2022
New!Reduction in catecholaminesSafetyViral infectionImprov. resp functionAnticoagulation OthersARDSCase of the weekCase reportCOVID-19Critical CareECMO (VV or VA)
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Summary
CoW 26/2022 – This case reports on a 55-year-old male patient who was transferred from an external hospital to Immenstadt hospital due to progressive respiratory deterioration with confirmed COVID-19 pneumonia.
Case presentation
Prior to this, he was admitted to a peripheral hospital following a deterioration in his general condition including fever. At this hospital he initially received oxygen therapy via nasal cannula and dexamethasone therapy for a total of 16 days. However, respiratory wise he continued to deteriorate with subsequent transfer to the intensive care unit (ICU). Hence, high-flow oxygen/non-invasive ventilation therapy was started, but there was a continuous clinical deterioration with O2 requirements of 90-100% via non-invasive ventilation. Finally, endotracheal intubation was performed and the patient was subsequently transferred to Immenstadt hospital
His vaccination status was as follows: vaccinated 3x COVID-19 (2x Biontech, 1x Moderna), but no titer response to the first two vaccinations, but only to the 3rd vaccination
The patient’s medical history further included follicular lymphoma, post-radiotherapy, current chemotherapy, nicotine abuse, hypercholesterolaemia and obesity
On admission to Immenstadt hospital, the patient was intubated with the following settings: paO2 59 mmHg, paCO2 46 mmHg, FiO2 of 1.0, positive end-expiratory pressure (PEEP) 14 cmH2O; his blood pressure was 89/52 mmHg under ongoing norepinephrine therapy (2.2 mg/h)
Due to the highly critical acute situation of refractory acute respiratory distress syndrome (ARDS) and the rapid dynamics of deterioration, veno-venous (vv) extracorporeal membrane oxygenation (ECMO) therapy was implanted immediately after admission. Given a difficult puncture attempt of the right internal jugular vein and status after port implantation in the right subclavian vein, a bifemoral insertion technique was chosen, with the reflow cannula via the femoral vein on the left side
After initiation of the extracorporeal circuit, lung-protective ventilation could be performed. The patient was then prone-positioned several times. Subsequently, FiO2 could be reduced to 0.5. PaO2/FiO2 at that time was 133 mmHg
To measure the transpulmonary pressure, a PESO catheter was placed and the PEEP was adjusted according to the measured values which varied considerably with positioning
Computed tomography showed severe COVID changes, but also pneumonic consolidations. Calculated antibiotic therapy was started with meropenem; in addition, voriconazole was administered in a calculated manner due to radiological suspicion of COVID-19-associated pulmonary aspergillosis. This was later confirmed in the bronchoalveolar lavage. Over time, the patient developed recurrent severe infections, partly with multi-resistant pathogens and also with herpes simplex Virus
Due to a pronounced hyperinflammatory state with markedly elevated plasma concentrations of C-reactive protein (CRP 347 mg/l), a CytoSorb hemoadsorber was additionally integrated into the vvECMO circuit with the aim of controlling the hyperinflammatory situation
Treatment
One treatment with CytoSorb was performed for a total treatment duration of 24 hours
The CytoSorb adsorber was directly integrated into the vvECMO circuit as a bypass
Anticoagulation was performed according to internal standard with Argatroban controlled via PTT and ECA-test
Measurements
Hemodynamics and norepinephrine requirements
Inflammatory parameters
Results
The catecholamine dose (norepinephrine 2.1 mg/h) initially required to maintain an adequate mean arterial pressure could be significantly reduced under adsorber therapy and fluid substitution. After 24 h, norepinephrine requirement was 0.5 mg/h with subsequent further decreasing values
A decrease in the elevated CRP levels (347 mg/l) was not observed during the treatment period
Patient Follow-Up
Over time, continuous renal replacement therapy (CRRT) using continuous veno-venous hemodialysis (CVVHD) was indicated due to the development of acute renal failure
Initially, the patient had a protracted course with septic multi-organ failure and a difficult sedation regime (inhalative sedation)
He also suffered from diffuse hemorrhages and microthrombi in his extremities with severe necrosis of all fingers of the left hand as a result of severe disseminated intravascular coagulation
Repeated initiation of broad-spectrum antibiotic therapy with evidence of partly multi-resistant pathogens in the bronchial secretions as well as in the bloodstream
Weaning was difficult and prolonged in the context of the underlying disease
A CT scan performed because of ongoing drowsiness that showed acute subdural bilateral hematomas with a slight midline shift. Anticoagulation in the context of the extracorporeal ECMO circuit was immediately discontinued and vvECMO therapy had to be stopped
Initially, pulmonary stabilization was only partially successful without ECMO and ventilation pressures outside the lung-protective range had to be tolerated for a short time
After infection control though, there was a steady improvement in compliance with consecutive pulmonary stabilization, and the patient could be switched to discontinuous weaning
Ventilation intervals via the nasal cannula with intermittent relief could be steadily increased
After 8 weeks of intensive therapy, the patient could be decannulated with good vigilance, respiratory mechanics and good pulmonary gas exchange
Unfortunately, the patient was still COVID-19 positive after several months. A mutation analysis revealed the virus type to be Omicron (BA.2-like). Antiviral triple therapy with Remdesivir, Paxlovir and Sotrovimab was therefore initiated
Early neurological rehabilitation has been organised and is expected to start soon
Conclusions
In this patient with COVID-19, refractory ARDS and vvECMO support, the combination of extracorporeal oxygenation, adsorber therapy and volume/catecholamine therapy resulted in clear clinical stabilization both in regards to his hemodynamic and respiratory parameters during the highly critical phase
A hyperinflammatory state could be controlled initially, but severe septic episodes occurred repeatedly later on
Treatment with CytoSorb was safe and use of the adsorber together with vvECMO therapy was feasible without technical problems.
The last trade, 3.5 mil shares on a Friday... That should lift some eye brows...
Case of the Week
Literature Database
Use of the CytoSorb® filter for elimination of residual therapeutic argatroban concentrations during heparinized cardiopulmonary bypass for heart transplantation
Andreas Koster1, Helmuth Warkentin1, Vera von Dossow1, and Michiel Morshuis2 | 1 Institute of Anesthesiology and Pain Therapy, Bad Oeynhausen, Germany | 2 Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Ruhr-University Bochum, Germany Perfusion 2022; epub
06/08/2022
New!Peer Reviewed Published DataTransplantCardiac surgeryCase of the weekCase reportCPBDrug removalIntra-Op
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Summary
CoW 25/2022 – This case reports on a 34-year-old male patient with a medical history of a correction of Fallot tetralogy, who was scheduled for heart transplantation.
Summary
This is a case report about a 34-year-old patient who, after a five week wait in hospital, was offered a donor heart that had to be transplanted within 2 hours. Because of a history of heparin-induced thrombocytopenia (HIT), the patient had been placed preoperatively on the anticoagulation drug argatroban for which there is currently no reversal agent. Despite ceasing the continuous infusion of argatroban immediately, concentration only declined from 0.60 mug/ml to 0.58 mug/ml before surgery, with the activated clotting time (ACT) value remaining very high (223 s). Microvascular bleeding was observed on chest incision, therefore a CytoSorb column was integrated into the system of the heparin-anticoagulated cardiopulmonary bypass (CPB) circuit, with a flow of 400 mL/min provided during the 150 mins of extracorporeal circulation. The argatroban concentration after weaning from CPB was 0.04 mug/ml and satisfying hemostasis was achieved after protamine administration. Despite severe bleeding within the context of perioperative use of argatroban having been described, the 12-h postoperative blood loss was only 580 mL. The authors note that the availability of a technology for quick elimination of high therapeutic concentrations of argatroban may have a significant impact on the safety profile of this drug, and that the use of CytoSorb might be an effective tool that has the potential to fulfil these criteria.
Comment from CytoSorbents
Argatroban is a direct thrombin inhibitor used instead of heparin for anticoagulation in cases of heparin-induced thrombocytopenia. This is the first published clinical case report that suggests a potential relevant removal of argatroban, but there are a number of other published papers (case reports / case series) that confirm the feasibility of argatroban anticoagulation without the need for additional precautions. Relevant in-vitro removal of argatroban has been shown, however, with the exception of this case report, there has been no signal towards clinically important removal from the published literature. Based on the currently available, inconclusive data, we recommend regular monitoring of aPTT when argatroban is used as anticoagulant during CytoSorb application.
Case presentation
The patient further revealed severe biventricular dysfunction requiring moderate inotropic support as well as multiorgan dysfunction (Model of End Stage Liver Disease excluding International Normalized Ratio [INR] (MELD XI) score of 12.3)
Due to a previous history of heparin-induced thrombocytopenia (HIT), systemic anticoagulation with argatroban was initiated and monitoring of the drug was performed with a target plasma concentration of 0.4–1.0 µg/ml
After a five week wait in hospital, a donor organ was finally offered, which, however, had to be transplanted within 2 hours due to logistical reasons
The infusion of argatroban was immediately stopped and blood samples taken to measure the actual argatroban plasma concentration
Despite ceasing the continuous infusion of argatroban immediately, concentration only declined from 0.60 µg/ml to 0.58 µg/ml within 2 hours before surgery, with the activated clotting time (ACT) value remaining very high (223 s)
With chest incision, 1 g of tranexamic acid was given to the patient and 0.5 g added to the cardiopulmonary bypass (CPB) system
During sternotomy, massive coagulopathy was evident and, as dialysis or continuous hemofiltration do not result in significant clearance of argatroban plasma levels, it was decided to incorporate a CytoSorb hemoadsorption column into the CPB circuit for possible enhanced extracorporeal elimination of argatroban
Treatment
One CytoSorb hemoadsorber was provided during the 150 mins of extracorporeal circulation
The CytoSorb column was integrated into the system of the heparin-anticoagulated CPB circuit. No hemofiltration was performed. During CPB, two units of red blood cell (RBC) concentrates were transfused
Blood flow rate: 400 mL/min
Measurements
Hemodynamics and need for inotropes
Argatroban plasma concentrations
Hemostasis as well as perioperative blood loss
Results
Weaning from CPB was possible with moderate inotropic support
Argatroban concentration declined from 58 µg/ml to 0.04 µg/ml during hemoadsorption
This was associated with a satisfying hemostasis after protamine administration with only modest microvascular bleeding observed in the operation field. The 12-h postoperative blood loss was only 580 mL
Patient Follow-up
The chest could be closed 1 hour after the end of CPB and the patient was transferred to the intensive care unit
Conclusion
This is the first report about the use of the CytoSorb column to eliminate high therapeutic concentrations of argatroban
The authors note that the availability of a technology for quick elimination of high therapeutic concentrations of argatroban may have a significant impact on the safety profile of this drug, and that the use of CytoSorb might be an effective tool that has the potential to fulfil these criteria.
New on PubMed
Corona, Acute Ischemic Stroke, Malignant Cerebral Edema, and Hemo-adsorption: A Case Report
Mehul Shah et al. Indian J Crit Care Med. 2022 Feb.
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Indian J Crit Care Med
. 2022 Feb;26(2):235-238.
doi: 10.5005/jp-journals-10071-24116.
Authors
Mehul Shah 1 , Zakaria Kaidawala 1 , Arun Shah 2 , Rushi Desphande 3
Affiliations
1 Department of Critical Care Medicine, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India.
2 Department of Neurosciences, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India.
3 Department of Nephro Critical Care, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, Maharashtra, India.
PMID: 35712732
PMCID: PMC8857715
DOI: 10.5005/jp-journals-10071-24116
Cite
Abstract
Background: COVID-19 infection can be associated with systemic hyperinflammation, hypercoagulable state, vasculitis, and cardiomyopathy leading to multiorgan failure. Use of extracorporeal blood purification has been shown to mitigate the cytokine storm, improving hemodynamic stability and pulmonary function.
Case summary: We report a case of a young patient with malignant cerebral edema due to acute cerebrovascular accident, with COVID-19. He was taken up for life-saving decompression craniotomy amidst the cytokine storm and multiorgan failure, and was treated with steroids, antibiotics, and Cytosorb® therapy for the cytokine storm. IL-6 and PCT levels were reduced by 99.5 and 98.6%, respectively. Vasopressors were stopped on day 4 and successfully weaned off ventilator support by 2 weeks of tracheostomy. He was de-cannulated and discharged neurologically stable on day 32.
Conclusion: Timely detection of COVID-19 and anti-inflammatory and hemo-adsorption measures may be helpful in modulating cytokine storm, thereby reducing morbidity and mortality.
How to cite this article: Shah M, Kaidawala Z, Shah A, Desphande R. Corona, Acute Ischemic Stroke, Malignant Cerebral Edema, and Hemo-adsorption: A Case Report. Indian J Crit Care Med 2022;26(2):235-238.
Keywords: Acute ischemic stroke; COVID-19; Corona; Cytosorb;
Case of the Week
Literature Database
Use of CytoSorb in a patient with hemorrhagic shock and multiple organ failure due to complicated secondary cesarean section
Dr. Mirko Brenni und Dr. Julien Marrel | Department for Anesthesiology, Intensive Care and Emergency Medicine, See-Spital Horgen, Horgen, Switzerland
06/15/2022
New!Case of the week
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Summary
CoW 24/2024 – This case reports on a 31-year-old previously healthy female patient, who was admitted post-operatively to the intensive care unit (ICU) with hemorrhagic shock and dilutional/ disseminated intravascular coagulopathy following secondary cesarean section with uterine atony, after already two revisions and ultimately an emergency hysterectomy.
Case presentation
On admission to the ICU, the patient was ventilated (pressure-controlled ventilation, with an FiO2 of 0.8), hemodynamically unstable with high catecholamine requirements. For hemodynamic stabilization, the patient was given norepinephrine up to 70 µg/min and dobutamine up to 300 µg/min in addition to fluid resuscitation. Moreover, the intravascular oncotic pressure was increased by an albumin infusion. While in shock, lactate levels were 10 mmol/l accompanied by severe metabolic acidosis
Also, following perioperative mass transfusion (including 9 red cell concentrates, 12 litres of Ringer’s solution) in postpartum hemorrhagic shock, she had dilutional and disseminated intravascular In accordance with repeated rotational thromboelastometry (ROTEM) measurements and a confirmed decrease in hemoglobin and platelet levels, as well as an increased bleeding tendency with prolonged aPTT, increased INR and fibrinogen deficiency, she received coagulation factors (a total of 15 g fibrinogen, 4500 IU human prothrombin complex (PPSB), 6000 IU blood coagulation factor XIII, 2000 mg tranexamic acid, 6 g calcium) as well as two platelet concentrates. As a result, her coagulative state was largely normalized intraoperatively under ROTEM control, and there were no further indications of post-operative bleeding
Chest X-ray examination showed bilateral pleural effusions and evidence of pulmonary hyperhydration, most probably due to the initial massive volume replacement therapy with increased capillary leakage, however without signs of pulmonary infiltrates
There was also a marked increase in troponin and creatine kinase values. Given the hemorrhagic shock situation, it was assumed that there was ischemic myocardial damage in the context of a type 2 acute coronary syndrome
Several hours post-operatively, inflammatory markers were clearly elevated: leukocytes 18.4 G/l, C-Reactive Protein [CRP] 62.5 mg/l and Interleukin [IL-6] 119 ng/l
Due to a confirmed nitrite-positive urinary tract infection, antibiotic therapy with co-amoxicillin was started for a total of 7 days. Repeated urine cultures, however, were negative on all measurements, while no bacterial growth could be detected in subsequent microbiological examinations
On the first postoperative day, there was also a marked increase in aminotransferases (aspartate aminotransferase [AST] 779 U/l, alanine aminotransferase [ALT] 132 U/l) indicating a shock-induced ischemic hepatopathy
Moderate ascites with anasarka was also found in the context of the pronounced fluid resuscitation. During the post-operative course, 1000-3000 mls of wound drainage per day was recorded
Due to acute anuric renal failure with hyperkalemia and hyperphosphatemia, continuous renal replacement therapy (CRRT) was started early, i.e. about 2 hours after admission to the ICU
Given the pronounced hemodynamic instability with progressive multi-organ failure in the context of severe hyperinflammation following mass transfusion, a CytoSorb cytokine adsorber was started simultaneously with CRRT
Treatment
Treatment with CytoSorb was performed for a period of about 48 hours
CytoSorb was used in combination with CRRT (Prismaflex, Baxter) run in CVVHDF mode
Anticoagulation: regional citrate. After the onset of citrate accumulation in the context of the most severe shock state with severe lactic acidosis, continuous veno-venous hemodiafiltration (CVVHDF) could be continued without problems following adjustment of hemodiafiltration settings
Position of the CytoSorb adsorber: post-hemofilter
Measurements
Hemodynamics and norepinephrine requirements
Lactate
Inflammatory parameters (CRP, Procalcitonin [PCT], ferritin, IL-6)
Fluid balance (colloids and crystalloids)
Oxygenation/ventilation
Results
Catecholamine therapy with norepinephrine could already be reduced to 3-5 µg/min 24 hours after initiation of combined CRRT/CytoSorb therapy after generous fluid substitution including album administration
Lactate levels also normalized on the first postoperative day
One day post-operatively, leukocytes were 14.1 G/l, CRP 72.5 mg/l, PCT 1.7 ng/ml, ferritin 787.7 µg/l and IL-6 86.4 ng/l
Following hemodynamic stabilization, consistent negative balancing could be achieved from day 4 onwards
The clinical pulmonary hyperhydration improved daily under negative balancing while chest X-ray examination showed that the pleural effusions had regressed. There was no evidence of transfusion-associated acute lung injury (TRALI). Weaning was also unproblematic, extubation was performed after neurological improvement on day 7
Patient Follow-Up
Due to a recurrent febrile episode in the antibiotic window, another sampling was performed, confirming the growth of Pseudomonas aeruginosa and Enterococcus faecium in the abdominal wound discharge. Consequently, antibiotic therapy was initially changed to piperacillin/tazobactam and daptomycin (for acute renal failure), and was then, according to the resistogram, switched from piperacillin/tazobactam to meropenem and continued for a total of 14 days. Following another recurrence of fever and ultrasound-guided puncture of an intra-abdominal hematoma, Candida albicans was detected in the collected sample After initiating antifungal therapy with fluconazole, inflammatory parameters decreased over time
After a total of 7 days of CVVHDF with an increase in diuresis, a first discontinuation attempt was started a few days later, which resulted in a renewed increase in creatinine and urea plasma levels. Therefore, intermittent hemodialysis was started and continued until transfer of the patient to a rehabilitation unit
Following an initial delayed recovery phase (despite reduced sedation, vigilance was still reduced), extubation was finally achieved without complications after a total of 7 days of invasive ventilation. Gas exchange was unproblematic. Due to persistent dyspnoea, a lung scintigraphy was performed without evidence of pulmonary embolism
After extubation, the patient was temporarily disoriented with hallucinations, which was interpreted as multifactorial delirium. The symptoms improved rapidly and there were no cognitive impairments. In the course of the patient’s stay, she developed loss of vision in the right eye, which, after magnetic resonance and ophthalmological examination, was interpreted as ischemic optic neuropathy in the context of the severe shock event
During the entire intensive care stay, the patient required a total of 7 units of red blood cells. Substrates remained within the normal range and erythropoietin was administered weekly in the presence of dialysis-dependent renal insufficiency with hyporegenerative anemia. At discharge, severe anemia persisted with an Hb of 63 g/l, however with measurable reticulocytosis.
The patient was discharged to a rehabilitation facility after a total hospital stay of 31 days
Conclusions
In this patient with hemorrhagic shock and multiple organ failure due to complicated secondary cesarean section, the post-operative use of CytoSorb, in addition to correcting hypoalbuminemia, led to hemodynamic stabilization by controlling hyperinflammation
According to the authors, CytoSorb therapy in this complex case presumably contributed to gaining control over the hyperinflammation triggered by the initial mass transfusion within a few hours
Hemoadsorption with CytoSorb in combination with CRRT was safe and easy to perform in this challenging setting.
Case of the Week
Literature Database
Urgent Coronary Artery Bypass Grafting Complication by Systemic Inflammatory Response from Fulminant Herpes Zoster Successfully managed with Adjunct Extracorporeal Hemoadsorption: A Case Report
Zaki Haidari1, Wilko Weißenberger1, Bartosz Tyczynski2, Ender Demircioglu1, Efthymios Deliargyris3, Martin Christ4, Matthias Thielmann1, Mohamed El Gabry1, Arjang Ruhparwar1 and Daniel Wendt1 1 Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, Essen, Germany 2 Department of Nephrology, University Hospital Essen, Essen, Germany 3 Cytosorbents Inc., Princeton, USA 4 Department of Cardiology and Intensive Care Medicine, Knappschaftskrankenhaus Bottrop, Bottrop, Germany J Clinical Medicine 2022; 11:3106
06/08/2022
New!Peer Reviewed Published DataReduction in catecholaminesSafetyViral infectionCardiac surgeryCase of the weekCase reportCPBCritical CareCRRT (pre or post filter)Inflammatory parametersIntra-Op
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Summary
CoW 23/2022 – This case reports on a 56-year-old man who presented with unstable angina pectoris and severe coronary artery stenosis.
Summary
In this case report a 56 yr old man presented to hospital requiring complex cardiac surgery complicated by an outbreak of herpes zoster infection. After clinical and inflammatory improvement (requiring an 8 day stay in intensive care), he was taken for coronary artery bypass graft surgery. Immediately on induction of anesthesia, he became hemodynamically unstable requiring noradrenaline (>0.75 µg/kgbw/min). This situation worsened again once he was placed on cardiopulmonary bypass (noradrenaline 1.5 µg/kgbw/min). The patient then had a CytoSorb adsorber added to the bypass circuit resulting in stabilization of this ongoing acute situation (noradrenaline 1.0 µg/kgbw/min). His post-operative course was complicated requiring maximum pharmacological and blood product support, as well as transfer onto veno-venous extracorporeal membrane oxygenation (vvECMO). He was also placed on renal replacement therapy, including 72 hours of CytoSorb hemoadsorption (3 adsorbers for 24 hrs each). By post op day 2 his hemodynamic status, lactate levels and inflammatory parameters were all improving. Despite the fact that the patient then developed acute respiratory distress syndrome, he eventually went on to fully recover, and was asymptomatic at 6 month follow up. In this patient with a profound systemic inflammatory response during coronary artery bypass surgery and reactivated herpes zoster resulting in significant clinical instability, use of CytoSorb both intra- and post-operatively helped stabilize hemodynamics and reduce inflammatory markers suggesting that hemoadsorption was an important contributor to the favourable outcome. In conclusion this case suggests that hemoadsorption may be a vital adjunct therapeutic option for the management of a profound systemic inflammatory response in a patient requiring urgent cardiac surgery.
Case presentation
The patient’s history included arterial hypertension, severe chronic obstructive pulmonary and peripheral artery disease
Coronary angiography revealed severe three-vessel disease with high-grade stenoses of the left main, the proximal left, the anterior descending and the the ramus intermedius coronary arteries, and an occluded right coronary artery
Transthoracic echocardiography showed a good left ventricular function without any sign of valve dysfunction
Preoperative workup revealed proximal stenosis of the left subclavian artery with subclavian steal syndrome
During physical examination on admission, well-de?ned grouped vesicles could be identi?ed on an erythematous background with a segmental nerve distribution of the left thorax (Th2-3)
After dermatologic consultation, a clinical diagnosis of herpes zoster was made and antiviral therapy with intravenous acyclovir in combination with analgesics and topical therapy was started. The diagnosis was based on the classical clinical presentation and cutaneous ?ndings
The patient was under continuous monitoring and intravenous heparin and nitroglycerin therapy in the intensive care unit (ICU) and was evaluated by the dermatologists every second day
After clinical and in?ammatory improvement (eight days later), CABG surgery was performed
However, immediately after induction of anesthesia, hemodynamic instability developed requiring norepinephrine support of >0.75 µg/kg/min to maintain a systolic blood pressure of 80 mmHg
Moreover, this hemodynamic instability further worsened after going on-pump with norepinephrine requirements reaching 1.5 µg/kg/min
At this juncture, the decision was made to integrate a CytoSorb hemoadsorption device into the cardiopulmonary bypass (CPB) circuit to stabilize the ongoing acute situation
His post-operative course was complicated by an unusually exaggerated increase in procalcitonin (PCT, 344 ng/mL) and interleukin 6 (IL-6 – 66,745 pg/mL) requiring maximum pharmacological and blood product support, as well as transfer onto veno-arterial extracorporeal membrane oxygenation (vaECMO). He was also placed on renal replacement therapy, including another 72 hours of CytoSorb hemoadsorption
Treatment
One CytoSorb hemoadsorber was used intraoperatively. Additionally, 3 consecutive hemoadsorption treatments were applied for 24 hours each during the postoperative period
Intraoperatively, the CytoSorb adsorber was integrated into the CPB circuit. During the postoperative period, adsorbers were run in conjunction with continuous renal replacement therapy (CRRT)
Measurements
Hemodynamics and requirements for vasoactive substances
Markers of hyperinflammation
Lactate levels
Results
Despite maximal supportive and adjunctive therapy including CytoSorb, high vasopressor support (1.0 µg/kg/min) was required during and after weaning from CPB and subsequent veno-arterial extracorporeal membrane oxygenation (vaECMO) therapy was necessary to reduce the vasopressor needs. During the second hemoadsorption session including 3 more CytoSorb treatments, his hemodynamic status improved considerably
During the course of postoperative CytoSorb therapy, there was a gradual reduction in the circulating in?ammatory markers (IL-6 from 66,745 pg/mL to negligible levels by postoperative day 7, PCT also continuously decreased) coinciding with clinical improvement
Treatment was further associated with a decrease in lactate plasma levels from 11.5 mmol/l to normal levels by postoperative day 7
Patient Follow-up
After hemodynamic stabilization and decreasing lactate and in?ammatory parameters, vaECMO therapy was removed on the second postoperative day
The patient developed acute respiratory distress syndrome (ARDS) and required veno-venous (vv) ECMO therapy on postoperative day 3
Following gradual respiratory improvement, vvECMO was explanted on the 15th postoperative day
A broncho-alveolar lavage did not identify any evidence of herpes simplex or COVID-19 infection
After percutaneous tracheostomy, weaning from mechanical ventilation was started
At 6 months follow-up, the patient was asymptomatic and active
Conclusion
In this patient with a profound systemic inflammatory response during coronary artery bypass surgery and reactivated herpes zoster resulting in significant clinical instability, use of CytoSorb both intra- and post-operatively helped stabilize hemodynamics and reduce inflammatory markers suggesting that hemoadsorption was an important contributor to the favourable outcome
In conclusion this case suggests that hemoadsorption may be a vital adjunct therapeutic option for the management of a profound systemic inflammatory response in a patient requiring urgent cardiac surgery.
Antithrombotic Drug Removal from Whole Blood Using Haemoadsorption with a Porous Polymer Bead Sorbent
Ritu Tripathi et al. Eur Heart J Cardiovasc Pharmacother. 2022.
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Eur Heart J Cardiovasc Pharmacother
. 2022 Jun 3;pvac036.
doi: 10.1093/ehjcvp/pvac036. Online ahead of print.
Authors
Ritu Tripathi 1 , Jesus Morales 1 , Victoria Lee 1 , C Michael Gibson 2 , Michael J Mack 3 , David J Schneider 4 , James Douketis 5 , Frank W Sellke 6 , E Magnus Ohman 7 , Vinod H Thourani 8 , Robert F Storey 9 , Efthymios N Deliargyris 1
Affiliations
1 CytoSorbents Medical Inc. Princeton, NJ, USA.
2 The Baim Institute and Harvard Medical School, Boston MA, USA.
3 Baylor Scott & White Health, Baylor Scott & White Research Institute, Dallas, TX, USA.
4 Department of Medicine - Cardiovascular Research Institute, University of Vermont, Burlington VT, USA.
5 Vascular Medicine and General Internal Medicine, St. Joseph's Healthcare Hamilton, McMaster University, ON, Canada.
6 Division of Cardiothoracic Surgery, Alpert Medical School of Brown University, Providence RI, USA.
7 Duke Clinical Research Institute, Duke Heart Center, Duke Program for Advanced Coronary Disease, Duke University Medical Center, Durham, NC, USA.
8 Department of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA, USA.
9 Cardiovascular Research Unit, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.
PMID: 35657375
DOI: 10.1093/ehjcvp/pvac036
Cite
Abstract
Aim: To evaluate the ability of the DrugSorb™-AntiThrombotic Removal (ATR) haemoadsorption device utilizing porous polymer bead sorbent technology to remove 3 commonly used antithrombotic drugs from whole blood.
Methods: We evaluated the removal of apixaban, rivaroxaban, and ticagrelor by the DrugSorb-ATR haemoadsorption device in a benchtop clinical scale model using bovine whole blood. Blood spiked at clinically relevant concentrations of an antithrombotic agent was continuously circulated through a 300-mL DrugSorb-ATR haemoadsorption device at a flow rate of 300 mL/min. Drug concentration was monitored over 6 hours to evaluate drug removal. Results were compared to a control circuit without the haemoadsorption device.
Results: Removal rates at 30, 60, 120 and 360 minutes were: apixaban: 81.5%, 96.3%, 99.3% >99.8%; rivaroxaban: 80.7%, 95.1%, 98.9%, >99.5%; ticagrelor: 62.5%; 75%, 86.6%, >95% (all p<0.0001 vs. control). Blood pH and hematological parameters were not significantly affected by the DrugSorb-ATR haemoadsorption device when compared with the control circuit.
Conclusion: DrugSorb-ATR efficiently removes apixaban, rivaroxaban, and ticagrelor in a clinical-scale benchtop recirculation circuit with the bulk of removal occurring in the first 60 minutes. The clinical implications of these findings are currently investigated in patients undergoing on-pump cardiothoracic surgery in two U.S pivotal trials (ClinicalTrials.gov Identifiers: NCT04976530 and NCT05093504).
Why waste time with these continuing cases of the week, The device failed the all important German Endocarditis trial and the Refresh trial was never going to be completed as I constantly warned due to patient size and primary endpoint of AKI which was never going to met, and just like I said, the trial was ended permanently, so here you are at 7.5 cents presplit, I remember buying 100,000 shares in 2014 for 23 cents and sold for about $6.00 bucks post split for modest profit, I saw the writing on the wall.
NEWS -- CytoSorbents to Hold 2022 Annual Meeting of Stockholders Virtually
PRINCETON, N.J., June 2, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will host its Annual Meeting virtually on Tuesday, June 7, 2022, at 10:00 a.m. Eastern. Stockholders of record as of April 14, 2022 will be able to virtually join and submit questions, and those that have not yet voted will be able to vote their shares electronically at the meeting.
To participate in the virtual meeting, visit https://www.virtualshareholdermeeting.com/CTSO2022 and enter the 16-digit control number found on your "Important Notice Regarding the Availability of Proxy Materials" Proxy Card or voting instruction form you previously received.
The Annual Meeting webcast will begin promptly at 10:00 a.m. Eastern Time and online check-in will begin at 9:00 a.m. Eastern Time. We encourage stockholders of record to access the Annual Meeting 30 minutes prior to the start time, to allow ample time for check-in procedures. Technicians will be ready to assist with any technical difficulties you may have accessing the virtual Annual Meeting. A phone number where you can obtain technical assistance will be made available on the Stockholder Meeting Link 30 minutes prior to the Annual Meeting.
An archived recording of CytoSorbents' 2022 Annual Meeting webcast will be available under the Investor Relations portion of the Company's website at Events & Presentations - Cytosorbents, and will be available for no less than 90 days following the Annual Meeting.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
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Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
NEWS -- CytoSorbents Partners with Nikkiso to Distribute the PureADJUST Hemoperfusion Blood Pump and Supplies in 14 Countries
Stand-alone Blood Pump Business Model is expected to Enable Expanded Use and Increased Adoption of CytoSorb®
PRINCETON, N.J., June 1, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today announced that following a successful pilot program in three countries, the Company has signed an expanded non-exclusive agreement with Nikkiso Europe GmbH (Nikkiso) to distribute their PureADJUST stand-alone hemoperfusion pump and accessories in a total of 14 countries.
CytoSorbents Partners with Nikkiso to Distribute the PureADJUST Hemoperfusion Blood Pump and Supplies in 14 Countries
In addition to securing the rights to sell Nikkiso's stand-alone pump and accessories in Germany, Austria, and Luxembourg, CytoSorbents has entered into an expanded multi-country reseller agreement with Nikkiso covering the following countries: Belgium, Bosnia and Herzogovina, Croatia, Finland, France, Iceland, Lichtenstein, Poland, Serbia, Slovenia and Switzerland. CytoSorbents will also be able to provide field support services in these countries.
Mr. Yoji Wakabayashi, Chief Executive Officer of Nikkiso Europe GmbH commented, "We are pleased to partner with CytoSorbents to make our PureADJUST equipment and full range of consumables and accessories available to CytoSorbents' customers in these additional countries. PureADJUST's compact design, intuitive interface, and easy adsorber set up is the ideal solution to provide an additional platform to deliver CytoSorbents' industry-leading blood purification technology. We look forward to collaborating with CytoSorbents and growing our business worldwide together."
Dr. Christian Steiner, Executive Vice President, Sales and Marketing of CytoSorbents added, "This new business model unlocks a significant opportunity for us to increase CytoSorb usage. Today, it is very easy to start CytoSorb on critically ill patients who have developed kidney failure and are already on dialysis or continuous renal replacement therapy (CRRT). However, this accounts for only about 10% of patients in the ICU, where kidney failure often occurs late in the critical illness, resulting in delayed intervention with CytoSorb. Our new stand-alone blood pump offering makes it easy for physicians to start treatment with CytoSorb earlier, even before patients develop kidney failure. Early start of the therapy has been shown to be a key predictor of success and was highlighted in a number of studies. We believe this will result in more effective treatment, while significantly increasing the number of patients who could benefit from our therapy."
Mr. Chris Cramer, Vice President Business Development at CytoSorbents, stated, "We are excited to partner with a globally recognized leader like Nikkiso to enable our new stand-alone hemoperfusion pump business model. With each PureADJUST machine placed at a customer account, we now have the ability to drive additional usage of CytoSorb across the full range of approved indications in the ICU. In the future, we also believe that this business model will enable us to support "hospital-wide" applications, such as in the emergency room, surgery suites, and elsewhere."
Financial details of this agreement have not been disclosed.
About Nikkiso Medical
Nikkiso Medical is one of the world's leading manufacturers of products for both acute and chronic blood purification therapies. In 1967, Nikkiso developed Japan's first dialysis machine. Today, based on this time-proven technology, Nikkiso is the world's second largest manufacturer of dialysis machines and disposables and a market leader in Europe and Asia. Trusted for superior quality and reliability, over 100,000 Nikkiso devices for blood purification therapies worldwide are currently used by customers around the world. To learn more, visit https://www.nikkisomedical.com.
About Nikkiso Co., LTD.
Founded in 1953, Nikkiso has been a pioneer in creating and continuing to drive the market for medical equipment for dialysis and healthcare products, industrial special pumps and their system products, and CFRP aircraft components. Nikkiso's products, which are born from original concepts and sophisticated technologies, demonstrate their power under harsh and socially valuable environments in which "in the unlikely event" is unacceptable, and are highly regarded by our customers. We at Nikkiso will continue to develop our technological expertise and enhance our manufacturing capabilities to meet the expectations of our customers and the demands of society. To learn more, visit https://www.nikkiso.com.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Please Click to Follow Us on Facebook and Twitter
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
Case of the Week
Literature Database
Use of Cytosorb in persistent hyperinflammation associated with lung infiltrates and pleural effusion
Maria Ting Ting SINN | Intensive Care Unit, Tseung Kwan O Hospital, Tseung Kwan O, Hong Kong, SAR
06/01/2022
New!Other indicationsReduction in catecholaminesSafetyShock reversalImprov. resp functionAnticoagulation CitrateCase of the weekCase reportCritical CareCRRT post filterInflammatory parameters
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Summary
CoW 22/2022 – This case reports on a 63-year-old male, who was admitted to the hospital with a 2-month history of exertional shortness of breath, a periodic cough with purulent sputum and right pleuritic chest pain.
Case presentation
The patient was a chronic smoker and drinker. Past medical history included hypertension and hyperlipidemia
He had no documented fever and was TOCC-negative (travel, occupation, contact, and cluster history) i.e. had no risk of COVID-19 infection
While still in the accident and emergency department, the patient developed signs of severe hypotension with a drop in blood pressure to 79/58 mmHg requiring initiation of a dopamine infusion
Moreover, the patient was put on oxygen supplementation (through nasal cannula, 4 liters) to maintainarterial oxygen saturation (SpO2) of 94%
Subsequent chest X-ray revealed lung infiltrates and pleural effusion in the right lung
Blood test results on admission showed a white cell count of 42,900/µl, hyperlactatemia (3.51 mmol/l) as well as increased retention parameters
Initiation of empirical anti-infective therapy with piperacillin/tazobactam and doxycycline
The same day the patient was then transferred to intensive care unit (ICU) for close monitoring
On admission to the ICU, oxygen supplementation had to be increased to 6 liters to maintain an SpO2 of 94 % with a respiratory rate of 30/min
Due to progressive hemodynamic instability, norepinephrine administration had to be commenced at a dose of 1.6 mg/hour
Pigtail catheter insertion for drainage of the right pleural effusion
Over the next 2 days, the patient showed desaturation events, resulting in the start of high-flow oxygen therapy
Another chest X-ray revealed a decrease in the right pleural effusion, however a simultaneous increase in left upper zone infiltrates, so that the patient had to be electively intubated later that day
His condition continued to deteriorate, accompanied by progressive development of anuric renal failure one day later
Meanwhile, his hemodynamic instability had drastically worsened with increasing norepinephrine requirements up to 4.8 mg/hour. At that time the FiO2 was 1.0
The next day, continuous renal replacement (CRRT) was initiated and run with an oXiris hemofilter (two sessions) over the next three days, resulting in only a very minor improvement in hemodynamics (norepinephrine still 4.5 mg/hour) and oxygenation (FiO28)
In addition, two more mini-chest drains were inserted for the pleural effusion and a subsequent chest X-ray showed a decrease in right pleural effusion, but an increase in pulmonal infiltrates
Due to the persistent hyperinflammatory state, empirical vancomycin and hydrocortisone therapy was prescribed and sedation was intensified
With the rationale to control the hyperinflammation, CRRT was re-initiated and a CytoSorb hemoadsorber was additionally integrated into the circuit
Treatment
Two CytoSorb treatment sessions were performed with a pause interval between both sessions of 3 days (1st session for 22 hours, 2nd session for 10 hours). Importantly, both CytoSorb therapy session had to be terminated prematurely due to filter clotting issues – which, however, was verified as not related to the adsorber
CytoSorb was used in conjunction with CRRT run in CVVHD mode
Blood flow rate: 100-120 ml/min
Anticoagulation: regional citrate
CytoSorb adsorber position in the system: post-hemofilter
Measurements
Hemodynamics and catecholamine demand
Inflammatory status
Oxygenation
Results
After the start of CytoSorb therapy, the patient’s hemodynamic condition improved significantly with a decrease in norepinephrine requirements down to 2.4 mg/h. Two days after the cessation of the first adsorber, norepinephrine demand had further decreased to 0.8 mg/h while epinephrine had been weaned off from an initial dose of 0.8 mg/h two days previously. The second treatment cycle again resulted in further hemodynamic stabilization
C-reactive protein (CRP) decreased from 292 mg/L to 199 mg/L during the first treatment and to 88.5 mg/L two days later. At the same time, leukocytes also decreased to 27,000/µl. During the second treatment, CRP levels decreased further to 24.3 mg/L and leukocytes to 22,800/µl
Under combined CRRT/CytoSorb therapy, the oxygen demand also improved culminative with an FiO2of only 0.5 two days after termination of the first therapy session. During the second therapy session, FiO2 could be kept stable
Patient Follow-Up
Between the two treatment sessions (i.e. the pause interval), the patient again developed hypotension and type II (hypercapnic) respiratory failure. Muscle relaxant cisatracurium was prescribed for ventilator-patient desynchrony and a stress dose of hydrocortisone was given for potential relative adrenal insufficiency, while chest X-ray showed a decrease in the right pleural effusion and a decrease in infiltrates
Vancomycin and hydrocortisone therapy were gradually weaned while there was no more sedation needed after the end of CytoSorb therapy
Also doxycycline treatment was stopped one day after the second treatment cycle due to consistently negative microbiological findings
CRRT was discontinued after 10 days including three CRRT sessions with a total ultrafiltration volume of ~10 liters
However, the patient’s clinical condition gradually deteriorated over time and he died a few months after the initial event
Conclusion
In this case of a patient with persistent hyperinflammation associated with lung infiltrates and pleural effusion, combined therapy consisting of standard of care, CRRT and CytoSorb hemoadsorption was associated with hemodynamic stabilization, control of the hyperinflammatory response and an improvement in oxygenation
According to the authors, the use of CytoSorb successfully managed the hyperinflammation, leading to an improved clinical condition and shock reversal in this patient
CytoSorb was safe and easy to use.
Use of the CytoSorb® filter for elimination of residual therapeutic argatroban concentrations during heparinized cardiopulmonary bypass for heart transplantation
Andreas Koster et al. Perfusion. 2022.
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Perfusion
. 2022 May 26;2676591221093875.
doi: 10.1177/02676591221093875. Online ahead of print.
Authors
Andreas Koster 1 , Helmuth Warkentin 1 , Vera von Dossow 1 , Michiel Morshuis 2
Affiliations
1 Institute of Anesthesiology and Pain Therapy, Bad Oeynhausen, Germany.
2 Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Ruhr-University Bochum, Germany.
PMID: 35619539
DOI: 10.1177/02676591221093875
Cite
Abstract
Introduction: No antidote or established extracorporeal elimination strategy is available for argatroban. Hemadsorption facilitates elimination of smaller drugs.
Case report: A 34-year-old patient underwent urgent heart transplantation. Because of a history of heparin-induced thrombocytopenia, preoperative anticoagulation was performed with argatroban. Despite ceasing of the continuous infusion of argatroban 2 h before surgery, concentration only declined from 0.60 µg/ml to 0.58 µg/ml before surgery, and the activated clotting time (ACT) value shortly was 223 s. Microvascular bleeding had been observed when starting surgery. A CytoSorb® absorption column was integrated into the system of the heparin-anticoagulated cardiopulmonary bypass (CPB) circuit and a flow of 400 mL/min provided during the 2 h of extracorporeal circulation. The argatroban concentration after weaning from CPB was 0.04 µg/ml and satisfying hemostasis had been achieved after protamine administration.
Conclusion: Data indicate that the CytoSorb® absorption column might be an effective tool for quick extracorporeal removal of therapeutic concentrations of argatroban.
Keywords: Anticoagulation reversal; bleeding; coagulopathy.
Case of the Week
Literature Database
Successful treatment of severe quetiapine intoxication with CytoSorb hemoadsorption
Caterina Reuchsel Falk A. Gonnert | Department of Anesthesiology and Intensive Care Medicine, SRH Klinikum Gera, Gera, Germany | Journal of Clinical Pharmacy and Therapeutics 2022: epub
05/25/2022
New!Peer Reviewed Published DataSafetyStandalone (HP)Anticoagulation OthersCase of the weekCase reportCritical CareDrug removalIntoxication
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Summary
CoW 21/2022 – A 64-year-old female was admitted to the Emergency Department after she was found somnolent by her daughter.
Summary
In this case report a 64 yr old woman who had attempted suicide by ingesting an unknown amount of the tricyclic antidepressant, quetiapine, was admitted to intensive care in a deeply somnolent state. CytoSorb hemoadsorption was started on the second day of admission due to her not improving clinically, and potentially lethal levels of quetiapine being found in her blood and urine. Pre and post CytoSorb adsorber blood samples confirmed direct removal and there was a clear and rapid decrease in plasma levels of the drug over the following few hours. The following day the patient could be extubated and was alert and cooperative. CytoSorb was discontinued after 2 days, whereby the patient was discharged in to the care of psychiatry. The authors describe CytoSorb as an alternative novel therapeutic option for life threatening complications of quetiapine intoxication. In order to maintain optimal removal capacity it is recommended that the adsorber be changed after 8 – 12 hrs.
Case presentation
Due to a severe episode of recurrent depression, the patient had been undergoing partial day-care treatment in a peripheral hospital with several changes to her antidepressant therapy. As she did not show up for routine treatment and as no contact could be established by telephone, her daughter was contacted via the police, who then found her mother somnolent in her apartment
Upon arrival of the emergency doctor, a Glasgow-Coma-Scale (GCS) score of 10 was determined, accompanied by a blood pressure of 153/80 mmHg, normofrequent sinus rhythm, no widening of the QRS complex on the electrocardiogram (ECG), an SpO2 of 93% on room air, deep breathing, partly snoring, pupils isocoric and miotic
After a closer search of the apartment the next day, empty blisters of quetiapine tablets were found. In the Emergency Department, the patient was still soporific (GCS 8) with preserved protective reflexes, respiratory and hemodynamically stable, and unremarkable arterial blood gas analysis
Chest X-ray showed no clear pulmonary consolidations, no major pleural effusions or higher-grade congestions
Native and angio-computed tomography showed no occlusions of the brain-supplying arteries, inconspicuous basilar artery, and unspecific patchy milky opacity in the upper lobe of the lung
Subsequently, the patient was admitted to the intensive care unit (ICU)
Due to subfebrile temperatures up to 37.7°C, suspected infiltrates and nitrite-negative leukocyturia found on the chest X-ray and CT, blood cultures, urine and tracheal secretions were taken for microbiological diagnosis and a calculated antibiotic treatment was started with ampicillin plus sulbactam
The following day, additional blood and urine were sent for analysis revealing quetiapine intoxication with levels in the potentially lethal range (>1mg/l), other psychotherapeutic drugs were within the normal range
For primary toxin elimination and because of possible bezoar formation with the risk of mucosal ulceration, a gastroscopy was performed on the same day with recovery of small tablet remnants
For this, the patient was analgosedated, intubated and ventilated
Minor ulcerations of the gastric mucosa were found, hence pantoprazole (40 mg 2 x daily) was started
Since quetiapine is in principle not dialysable, a hemoadsorption procedure with CytoSorb was deemed a potential therapeutic option, which was then started the same day following placement of a Shaldon catheter into the right femoral vein
Treatment
In total, 2 hemoadsorbers were used for 40 consecutive hours
Hemoadsorption treatment was run in conjunction with a Multifiltrate machine (Fresenius Medical Care, Germany)
Blood flow rate: 100 ml/min
Enoxaparin was used for anticoagulation
Measurements
Quetiapine and norquetiapine levels pre- and post adsorber cartridge
Results
Measurements showed the pronounced direct removal of both substances, as well as a clear and rapid decrease in plasma quetiapine levels over the next few hours
Patient Follow-up
The next day, analgesia was stopped and the patient was alert and cooperative, so that she could be extubated without problems
Prior to this, a bronchoscopy was performed in which purulent secretions were aspirated from the left lung
CytoSorb treatment was discontinued after 2 days
One day later, the patient could be transferred to a psychiatric clinic
Conclusion
In this case, the use of CytoSorb following application of all available standard therapeutic measures helped to quickly and efficiently reduce quetiapine and norquetiapine to non-toxic serum levels and to stabilize the patient’s clinical condition
The decision to use CytoSorb in this patient was based on the rationale of its highly absorptive capacity and potential capability to bind excess levels of these substances
Compared to previous data (Giuntoli et al., IJAO 2019), this report confirms the direct removal of the drug based on pre and post cartridge measurements and might help to understand the pharmacokinetics of quetiapine overdose, particularly when hemoadsorption is applied for acceleration of the elimination process
Based on the observation of a potential saturation effect after around 8 hours, routine adsorber changes within 8-12 hours max might be recommended to maintain optimal removal capacity
Therefore, in the absence of a proven beneficial treatment regimen, the use of CytoSorb might represent an alternative treatment for life threatening complications of quetiapine intoxication.
NEWS -- CytoSorbents to Present at Two Upcoming Investor Conferences
MONMOUTH JUNCTION, N.J., May 19, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces management will present at two upcoming in–person investor conferences.
On Monday, May 23, 2022, Dr. Phillip Chan, CytoSorbents' Chief Executive Officer, will present at the UBS Global Healthcare Conference 2022 at 9:15 a.m. Eastern time. A live audio webcast will be accessible via the following Link. Company management will also meet with investors during the conference.
Kathleen Bloch, Chief Financial Officer of CytoSorbents, will also present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 4:00 p.m. Eastern time, with a live video webcast accessible via the following Link. Management will also hold investor meetings that day.
An archived recording of CytoSorbents' presentations at both investor conferences will be available under the Investor Relations portion of the Company's website at Events & Presentations - Cytosorbents, and will be available for 90 days.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Please Click to Follow Us on Facebook and Twitter
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
Case of the Week
Use of CytoSorb in a patient with acute renal failure and hyperbilirubinemia
Dr. Katarina Foraboschi | Anesthesiology and Intensive Care Medicine, Ordensklinikum Linz GmbH, Linz, Austria
05/18/2022
New!Other indicationsReduction in catecholaminesSafetyAnticoagulation OthersBilirubinCase of the weekCase reportCRRT pre filterImprov. hep. encephalopathyInflammatory parametersLiver failure
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Summary
CoW 20/2022 – This case reports on a 53-year-old male patient who was transferred from a peripheral hospital to Ordensklinikum Linz with initial manifestation of Hodgkin’s disease (stage IV/B/E, lymph nodes neck, bulks retroperitoneal, diffuse liver involvement, bone marrow involvement) as well as acute renal failure requiring hemodialysis.
Case presentation
Medical history also included type II diabetes mellitus, chronic bronchial asthma, arterial hypertension and hepatosplenomegaly
On admission, the patient had an American Society of Anesthesiologists (ASA) classification score of 3 and a Glasgow Coma Scale (GCS) score of 15
Additionally, he exhibited accompanying thrombocytopenia, pancytopenia as well as suspected atypical hemolytic syndrome
Initially, the patient was respiratory and hemodynamically stable. Catheterization was performed for volume balancing and optimization. In addition, the patient received albumin, insulin lispro in the context of his pre-existing diabetes mellitus II and a total of 2 red cell concentrates due to evident pancytopenia
On the following day, the patient was admitted to the intensive care unit following a deterioration in renal and liver parameters
The first dose of chemotherapy had no hemodynamic effects
One day later, however, the patient developed full-blown multi-organ failure including oliguric/anuric renal failure and liver failure with bilirubin levels up to (20 mg/dl) and incipient hepatic encephalopathy
Furthermore, the patient developed severe hemodynamic instability requiring initiation of norepinephrine up to 0.2 µg/kg/min
In addition, he was in a hyperinflammatory condition with elevated C-reactive protein (CRP) levels (25 mg/dl)
In the evening of the same day, continuous renal replacement therapy (CRRT) was started due to ongoing increases in his retention parameters with a simultaneous adjustment of antibiotic therapy with meropenem to 3x 2g
With the rationale of reducing the excessive bilirubin plasma levels, a CytoSorb hemoadsorber was additionally integrated into the CRRT circuit
The patient was breathing spontaneously throughout his course and only required intermittent respiratory support via nasal cannula (low-flow)
Treatment
Two treatments with CytoSorb were performed (1st treatment for 3 hours, 2nd treatment for 8 hours). The first adsorber had to be changed prematurely due to system clotting. Following the application of enoxaparin, the 2nd treatment session could be run without any problems
CytoSorb was performed in combination with CRRT (Multifiltrate Pro, Fresenius) run in hemodiafiltration mode (CVVHDF)
Blood flow rate: 250 ml/min
Anticoagulation: initially none, due to derailed plasma coagulation, following systemic clotting then anticoagulation with enoxaparin 40 mg systemically
CytoSorb adsorber position: pre-hemofilter
Measurements
Hemodynamics and norepinephrine dose
Inflammatory markers
Bilirubin levels
Renal function
Overall clinical condition
Results
Supportive hemodynamic therapy with norepinephrine could be significantly reduced on the first day and finally completely stopped after a total of 4 days
During treatment, CRP levels dropped to 16 mg/dl and subsequently continued to decrease to normal levels
CytoSorb treatment was also associated with a significant reduction in plasma bilirubin levels (down to 8 mg/dl after completion of CytoSorb treatment and a further spontaneous reduction thereafter)
Under combined standard CRRT and CytoSorb therapy, renal function continued to stabilize, and spontaneous diuresis resumed (1400 ml within 12 hours)
The patient’s clinical condition including the hepatic encephalopathy also improved rapidly under ongoing therapy
Patient Follow-Up
Discontinuation of CRRT after a total of 12 hours together with CytoSorb with significantly improved diuresis over the following days
At the time of documentation, the patient was still on chemotherapy, currently on a curative approach
At the time of transfer, the patient was cooperative, hemodynamically and respiratory stable
Conclusion
In this case of a patient with acute renal failure and hyperbilirubinemia, the use of CytoSorb in combination with other therapeutic measures including CRRT led to a significant and steady improvement of the critical situation, particularly due to the rapid stabilization in hemodynamics, a rapid and sustained reduction in bilirubin levels, and an improvement in renal function and his overall clinical condition
The primary goal of reducing hyperbilirubinemia and improving hepatic encephalopathy was rapidly achieved, without complications, and in a patient-safe manner.The clinical and laboratory improvement enabled a more rapid administration of chemotherapeutic agents, which, presumably, in combination with causal therapy, improved the patient’s final outcome
CytoSorb was easy and safe to use in this setting.
Dude, "demands $30 a share"? Get real and post something constructive like Andy.
Sorry dude. This company is a joke, this CEO is a joke, this management is a joke and this board is napping. Miracle device is also a joke. 7-11 sells more condoms and shampoo than this debacle.
Every shareholder of this junk deserves and demands $30 sp not $1.8, after 13 years of waiting for this sh$& to take off.
Successful treatment of severe quetiapine intoxication with CytoSorb hemoadsorption
Caterina Reuchsel et al. J Clin Pharm Ther. 2022.
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J Clin Pharm Ther
. 2022 May 10.
doi: 10.1111/jcpt.13668. Online ahead of print.
Authors
Caterina Reuchsel 1 , Falk A Gonnert 1
Affiliation
1 Department of Anesthesiology and Intensive Care Medicine, SRH Klinikum Gera, Gera, Germany.
PMID: 35537706
DOI: 10.1111/jcpt.13668
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Abstract
What is known and objective: While many drug poisonings are successfully treated with specific antidotes, intoxications with tricyclic antidepressants and/or atypical neuroleptics still represent a major challenge. Besides conventional approaches, a new hemoadsorption device might represent an opportunity for therapeutic detoxification.
Case summary: We report a 64-year-old female patient who attempted suicide by ingesting an unknown dose of quetiapine. Following application of all available standard diagnostic and therapeutic measures, she was admitted to the intensive care in a deeply somnolent state. Gastroscopy was performed necessitating analgo-sedation, intubation, and mechanical ventilation. Since quetiapine is in principle not dialysable, CytoSorb hemoadsorption was commenced resulting in a clear and rapid decrease in plasma levels of quetiapine and its metabolite norquetiapine over the next few hours. The next day, analgesia was stopped, the patient became alert, and cooperative so that she could be extubated without issues. CytoSorb blood purification therapy was discontinued after 2 days. One day later, the patient was transferred to a psychiatric clinic.
What is new and conclusion: We were able to quickly and efficiently reduce quetiapine and norquetiapine to non-toxic serum levels and to stabilize a critical situation using CytoSorb. Therefore, in the absence of a proven beneficial treatment regimen, the use of CytoSorb might represent an alternative for life-threatening complications of quetiapine intoxication. In particular, intoxications caused by lipophilic agents should be further evaluated.
Case of the Week
Literature Database
Use of CytoSorb as a stand-alone therapy in a patient suffering from sepsis and multiple organ dysfunction
Dr. Sachin Gupta | Narayana Super Speciality Hospital, Gurgaon, India
05/11/2022
New!Reduction in catecholaminesSafetySeptic ShockStandalone (HP)Improv. resp functionAnticoagulation HeparinARDSCase of the weekCase reportCritical CareInflammatory parametersMOF
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Summary
CoW 19/2022 – This case reports on a 67-year-old male patient, who was admitted to hospital suffering from a severe immunological response following his 2nd COVID-19 vaccination.
Case presentation
After admission, the patient’s vital signs were recorded revealing a reduced blood pressure of 96/52 mmHg as well as increased respiratory rate (30/min), and heart rate (148/min)
A reverse transcription–polymerase chain reaction (RT-PCR) analysis for a current SARS-CoV-2 infection proved negative
The sequential organ failure assessment (SOFA) and acute physiology and chronic health evaluation II (APACHE II) scores on admission were 17 and 29, respectively
He further exhibited severe metabolic acidosis as evidenced by an arterial pH of 7.04 and a lactate plasma concentration of 8 mmol/L
Additionally, oxygenation/lung function were already severely compromised (PaO2/FiO2 ratio of 78 mmHg) suggesting manifest acute respiratory distress syndrome (ARDS)
Consequently, the patient was immediately transferred to the intensive care unit (ICU)
The patient was placed on vasopressor support (baseline norepinephrine at 0.4 µg/kg/min and low dose vasopressin)
Furthermore, there were signs of renal dysfunction as serum creatinine had increased to 2.48 mg/dl
Elevated inflammatory markers such as interleukin – IL-6 (>5500pg/ml) and C-reactive protein (CRP, 212 mg/L) indicated severe hyperinflammation
Bilirubin levels were slightly increased (2.1 mg/dL) pointing towards compromised hepatic function most probably in the context of the ongoing hyperinflammatory response
Establishment of protocol-based volume therapy and administration of antibiotic therapy including meropenem, teicoplanin and colistin was instituted
Given his septic state with multiple organ failure unresponsive to standard therapy, the decision was made to initiate CytoSorb hemoadsorption therapy
Measurements
Hemodynamics and vasopressor requirements
Metabolic status
Inflammatory parameters
Respiratory parameters
Overall clinical condition and organ function
Treatment
Two consecutive treatments with CytoSorb were performed for 32 hours (both treatments for 16 hours each)
CytoSorb therapy was run as a stand-alone treatment
Anticoagulation: Heparin (200 U/h for 12 hours)
Results
After the first CytoSorb session, hemodynamics improved and norepinephrine dosage could be reduced from 0.4 µg/kg/min to 0.12 µg/kg/min after the second therapy session, while MAP was even rising. The patient’s elevated heart rate decreased from 148/min to 96/min
Treatment was accompanied by a normalization of arterial pH from 7.04 to 7.38 and a reduction in serum lactate levels from 6.8 mmol/L to 2.7mmol/L after the second CytoSorb treatment
After the two CytoSorb treatment sessions, there was a marked reduction in IL-6 levels from >5500pg/ml to 216 pg/ml while CRP levels had dropped from 212 mg/l to 178mg/l, indicating a clear control of the hyperinflammatory situation post treatment
Following the first CytoSorb treatment session, there was an improvement in respiratory parameters, as indicated by an increase in PaO2/FiO2 ratio from 78 to 120 mmHg followed by a further increase to 148 mmHg with a concomitant decrease in the respiratory rate to 24/min
The patient’s organ dysfunction and clinical condition also improved as both the APACHE ll and SOFA scores decreased from 29 to 14, and 17 to 9, respectively, during the course of treatment
Patient Follow-Up
The patient was completely weaned off vasopressors over the following days
He was discharged from the ICU to the normal ward after 9 days in a stable condition and was finally discharged from the hospital 16 days post admission
Conclusions
In this patient with sepsis and multiple organ dysfunction syndrome, treatment with CytoSorb in stand-alone mode was associated with stabilization in hemodynamics, resolution of metabolic acidosis, control of the hyperinflammatory response, as well as an improvement in lung function and his overall clinical condition
No complications were observed while using CytoSorb as stand-alone therapy and thetreatment was well tolerated.
7.44 cents presplit! Pathetic company!
Case of the Week
Combined Application of CytoSorb and Sustained Low Efficiency Dialysis (SLED) in Critical Patients
Jose Lucas Daza1, Yaroslad De la Cruz1, Gerardo Gutierrez1, Hernan Sarzuri1, Nestor Guarnizo2, Alexander Ariza3, Leonardo Marin4 | 1Nephrology, University of Buenos Aires, Argentina, |2Intensive Care Unit, Tolima University, Colombia, | 3Hematology, University of Buenos Aires, Argentina, | 4Nephrology, University del Valle - Cali, Colombia | Annals of Case Reports 2022; 7(2):807
05/03/2022
New!Peer Reviewed Published DataReduction in catecholaminesSeptic ShockImprov. resp functionAnticoagulation HeparinCase of the weekCase reportCritical CareIHD / SLEDInflammatory parameters
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Summary
CoW 18/2022 – A 41- year-old male patient with no pathological history presented to the hospital with colic-type abdominal pain in the right hypochondrium associated with a history of fever over a few days.
Summary
In this case report a 41 yr old patient with refractory septic shock and acute kidney injury (AKIN III) secondary to pancreatitis requiring pancreatectomy, colectomy and ileostomy, was given sustained low efficiency dialysis (SLED) plus CytoSorb. Two consecutive SLED & CytoSorb sessions were performed for 12 hrs each with a Genius 90 machine and blood flow rates around 120 ml/min. Over the following 48 hours, norepinephrine was able to be reduced from 1.2 µg/kg/min to 0.3 µg/kg/min after the first session and 0 after the second session. There was also a notable improvement in ventilatory parameters (paO2/FiO2 ratio up from 120 to 230 after the first session and up even further to 290 after the second session. Unfortunately, the patient presented with various complications over the following days including a massive pulmonary thromboembolism on day 29 from which he died. The authors then discuss the SLED modality which combines the benefits of continuous renal replacement therapy (CRRT) and intermittent hemodialysis (IHD) and present some comparative studies in this regard. They conclude by stating that, to date, no dialysis therapy modality shows clear superiority over others in terms of survival and recovery of renal function. For clinical cases with multi-organ systemic involvement associated with acute renal dysfunction requiring dialysis therapy in the context of anuria, they propose the use of SLED modality daily, combined with CytoSorb, pre-filter.
Case presentation
An ultrasound showed a lithiasis and obstruction in the bile duct
Subsequently, an endoscopic retrograde cholangiopancreatography (ERCP) was performed
Over the next 48 hours, his abdominal pain continued accompanied by persistent fever
Blood sample analysis revealed leukocytosis and increased pancreatic enzymes
Additionally, the patient developed arterial hypotension resulting in the diagnosis of distributive shock secondary to severe pancreatitis and he was admitted to the intensive care unit (ICU)
Here, fever persisted while blood cultures showed growth of Gram-negative bacteria followed by the initiation of wide spectrum antibiotic therapy
Another 48 hours later the patient had developed multiple organ failure with signs of peritonitis
Subsequent contrast-enhanced CT diagnostics showed diffuse pancreatic necrosis and intestinal ischemia, and an operation was scheduled
Following combined pancreatectomy, colectomy and ileostomy the patient developed refractory septic shock, cytokine release syndrome and acute anuric kidney injury AKIN III requiring initiation of sustained low efficiency dialysis (SLED)
With the rationale to control the excessive inflammatory response, a CytoSorb hemoadsorber was additionally integrated into the SLED circuit
Treatment
Two CytoSorb hemoadsorption sessions were applied for 12 hours each
CytoSorb was used in combination with SLED (Genius 90, Fresenius Medical Care)
Blood flow rate: 120-125 ml/min
Anticoagulation: sodium heparin bolus 5000 (1st session) and 5500 (2nd session) units
CytoSorb adsorber position: pre-hemofilter
Measurements
Hemodynamics and dosages of vasoactive substances
Inflammatory response
Oxygenation/lung function
Metabolic status
Renal function
Results
Over the following 48 hours, norepinephrine could be reduced from 1.2 µg/kg/min to 0.3 µg/kg/min after the first session and could be completely stopped after the second session. Vasopressin could be already tapered out during the first treatment session
Combined SLED & CytoSorb therapy was further associated with a control of the hyperinflammatory response (leucocytes from 26,000/µl to 9300/µl, C-reactive protein from 145 to 21 mg/dl)
Additionally, there was a notable improvement in oxygenation/lung function (PaO2/FiO2 ratio up from 120 to 230 mmHg after the first session and up even further to 290 mmHg after the second session)
Treatment also resulted in a resolution of metabolic acidosis (pH from 7.19 to 7.39, lactate from 5.6 to 1.1 mmol/l, HCO3 from 13 to 24 mmol/l)
Also renal retention parameters could be reduced to normal levels throughout the combined SLED & CytoSorb treatment period
Patient Follow-up
Following cessation of therapy, the patient developed several infectious and non-infectious complications resulting in a prolonged stay in the ICU
Additionally, a tracheostomy was performed
Unfortunately, over time the patient went on to develop a massive pulmonary thromboembolism on day 29 from which he finally died
Conclusion
In this patient with refractory septic shock and acute kidney injury (AKIN III) secondary to pancreatitis requiring pancreatectomy, colectomy and ileostomy, combined SLED & CytoSorb treatment resulted in hemodynamic stabilization, a control of the hyperinflammatory response, improvement in ventilatory parameters as well as resolution of metabolic acidosis and improvement in renal function
For clinical cases with multi-organ systemic involvement associated with acute renal dysfunction requiring dialysis therapy in the context of anuria, the authors propose the use of SLED modality daily, combined with a pre-filter set-up of CytoSorb.
CytoSorbents Reports First Quarter 2022 Results and Revises 2022 Outlook
Q1 2022 total revenue was $8.7 million, including product sales of $7.9 million. Core non-COVID-19 product sales were an estimated $7.6 million, and on a constant currency basis were comparable to core product sales a year ago. Product gross margins were 80%.
MONMOUTH JUNCTION, N.J., May 3, 2022 — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported unaudited financial and operating results for the quarter ended March 31, 2022.
First Quarter 2022 Financial Results
• Total revenue, including product sales and grant income, for Q1 2022 was $8.7 million, a decrease of 18% compared to $10.6 million in Q1 2021.
• Q1 2022 product sales were $7.9 million (including an estimated $7.6 million core non-COVID-19 sales and $0.3 million COVID-19 related sales) versus $10.1 million ($8.3 million core and $1.8 million COVID-related) in Q1 2021, a decrease of 22%. This decrease was driven primarily by a reduction in German direct sales, which were hampered by the impact of unprecedented rates of new COVID-19 infection in the country that persisted throughout Q1 2022, and to a lesser extent a weaker Euro. Germany sales were $3.8 million in Q1 2022 versus $5.9 million a year ago, a decline of 36%. Q1 2022 product sales were also lower by $0.6 million due to the stronger dollar compared to the euro.
• On a constant currency basis, core product sales in Q1 2022 would have been $8.2 million, and were comparable to core product sales of $8.3 million a year ago.
• As expected, COVID-19 related sales during the quarter were low, reflecting the low severity of current COVID-19 illness resulting from high rates of vaccination and natural immunity.
• Product gross margins improved to approximately 80% in Q1 2022, versus 77% in Q1 2021.
• The Company continues to have a solid balance sheet with cash and cash equivalents of $44.7 million (which includes $1.7 million in restricted cash) at March 31, 2022, and no debt.
Recent Operating Highlights
• More than 170,000 cumulative CytoSorb devices have been utilized worldwide as of March 31, 2022, an increase of 30% compared to more than 131,000 devices utilized as of the end of the first quarter of 2021.
• CytoSorbents continues to make progress in its company-sponsored clinical trials, most importantly announcing that the first patient was enrolled in April 2022 in the U.S. STAR-D (Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants) pivotal trial evaluating the DrugSorb™-ATR Antithrombotic Removal System to remove apixaban and rivaroxaban during cardiothoracic surgery.
• The first patient was enrolled in February 2022 in the PROCYSS Multicenter randomized controlled trial evaluating CytoSorb® to restore hemodynamic stability in patients experiencing refractory septic shock.
• Buildout of the Company’s new manufacturing facility in Princeton, New Jersey is approximately 95% complete. In April, the Company successfully completed its E.U. Notified Body audit of the manufacturing plant, with no major findings. Based on the positive audit, the Company is beginning the transition from its existing facility to the new manufacturing site. Management expects to receive full certification from its Notified Body in the coming months, which will allow device manufacturing and product shipments to begin from the new manufacturing facility.
• CytoSorbents recently appointed Jiny Kim, MBA to the Board of Directors. She brings an extensive background in the medical device industry, with significant experience in U.S. and international commercialization, sales, marketing and business development to support the Company’s growth initiatives, in particular the eventual commercialization of DrugSorb™-ATR in the United States.
• The Company is establishing a direct sales presence in the UK, the sixth largest medical device market in the world, and Ireland, part of its strategy to expand more territories in which CytoSorb is sold directly to customers.
• Multiple recent scientific publications and presentations highlighting the use of CytoSorb in critical care and cardiac surgery (see “Clinical Studies and Data Publications Update” below). In particular, new data from an expanded analysis of the U.S. CTC (CytoSorb Therapy in COVID-19) Registry on 56 critically ill COVID-19 patients with acute respiratory distress syndrome on life support with ECMO and treated with CytoSorb under FDA Emergency Use Authorization, continue to demonstrate high survival and improved clinical benefits with early intervention. These data were presented in an abstract at the 41st International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium, and will be presented this week at the 10th EuroELSO Congress in London, UK, along with multiple presentations at the CytoSorbents Lunch Symposium.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “A key takeaway from our first quarter results is that our core non-COVID-19 product sales were stable, on par with Q3 and Q4 2021, and comparable with Q1 2021 product sales on a constant currency basis. We did this despite the many business challenges and uncertainties created by COVID-19, the Russian-Ukraine war, inflation, currency exchange volatility, and other factors out of our direct control. As anticipated, COVID-19 related sales were nominal for Q1 2022 due to the low severity of recent COVID-19 infections, and primarily accounted for the difference in product sales from a year ago.”
“During Q1 2022, CytoSorb sales in Germany, the Company’s largest market, lagged as the country experienced its highest rates of COVID infections since the pandemic began. When we provided our 2022 outlook in early March, the Omicron wave appeared to be peaking, but was supplanted by a massive wave of BA.2 variant infections that drove a new peak of more than a half million new COVID-19 infections a day by the end of Q1 2022 - seven times higher than in the prior quarter and 21 times the peak seen a year ago. We have previously discussed how these high rates of COVID-19 indirectly reduce CytoSorb sales by impacting hospital budgets, staffing, elective procedure volumes, ICU capacity, and sale representative access due to visitation restrictions and illness. Fortunately, COVID-19 infection rates have dropped rapidly in the past several weeks. However, the BA.2 surge, which still accounts for nearly 100,000 new infections a day in the country, will likely delay the expected recovery in Germany. We are seeing a carryover of Germany Q1 sales trends to the current quarter, and although this may change, it has prompted us to conservatively revise our 2022 guidance (see “Revision of 2022 Outlook Guidance” below). That said, we are focused on the more important big picture where current trends portend an end to the global pandemic this year as COVID-19 is expected to morph into a much less virulent disease like seasonal influenza. When this happens, we want to be well-positioned to capitalize on what we expect will be a steady improvement and return to growth in our core business.”
Dr. Chan continued, “We remain confident that the slowdown in our growth is mainly driven by reversible COVID-related issues, and expect that these too shall pass. In the meantime, we have a solid balance sheet anchored by $44.7 million in cash and no debt at the end of Q1 2022 to weather the current turbulence. We are also managing our business proactively, continuing to invest in key areas such as our U.S. pivotal STAR-T and STAR-D trials, while instituting tighter cost controls to reduce our cash burn by an additional $2 million per quarter against budget. Our goal is to end this year with more than $30M in cash, which exceeds our projected cash need in 2023 and importantly, is expected to provide adequate funds through the anticipated enrollment completion of both the pivotal U.S. STAR-T and STAR-D trials. We also have the additional financial flexibility from our $15 million Bridge Bank term loan commitment to add debt if desired.”
“Meanwhile, we are not just waiting for conditions to improve. Rather, we are focused on building this company and solidifying our leadership as the treatment pioneer of life-threatening conditions using blood purification. We are laser-focused on four essential objectives that we believe are the key to driving sustainable, long-term value for shareholders:
• Open the U.S. market by obtaining FDA Marketing approval for DrugSorb™-ATR to remove blood thinning drugs during cardiothoracic surgery (see “Clinical update” below)
• Restore growth of core CytoSorb sales, driven by numerous initiatives (see below).
• Transition CytoSorb production to our new manufacturing facility and headquarters in Princeton, New Jersey this year (See “Operational Update” above)
• Forge and expand new and existing strategic partnerships to maximize the synergy between our technology and those of our partners, while creating new global opportunities for growth.
To provide more color on our growth strategy, we highlight several examples of important initiatives that we have been executing upon during the pandemic that are expected to drive improved results as the pandemic abates, as well as future, longer-term growth.
Near-term growth drivers
• Resume in-person sales from a strong customer base: Our active customer base accounts for the majority of our direct sales and grew by 20-25% at the start of the pandemic and has remained stable since. We are in close contact with these accounts and have confirmed that COVID-19 related issues, including its effect on staffing and numbers of ICU patients, are the primary issue for volatility in ordering. We believe a return to in-person selling will reinvigorate growth.
• New therapeutic area divisions: We have established three distinct therapy divisions within our commercial operations including Critical Care, Cardiovascular, and Liver/Kidney/other to develop these markets internationally under the leadership of dedicated medical and commercial subject matter experts, who will work closely with our sales teams and best serve the needs and interests of our customers. We have already seen our efforts bear fruit with now more than 150 cardiac surgery centers internationally who have begun to use CytoSorb to remove antithrombotic drugs during cardiac surgery, for example. We believe this infrastructure will yield many more similar successes across a broad array of applications.
• New exclusive private hospital chain partnerships: We are now the preferred supplier of hemoadsorption technology to the three largest hospital chains in Germany, including, as announced yesterday, Asklepios Group. A number of these hospitals are already current customers and our agreements facilitate access and sales of CytoSorb to these and all other relevant institutions within these hospital networks.
• Rise of Existing and New Applications: Among the many applications, we highlight:
Shock: Many studies have highlighted the ability of CytoSorb to remove inflammatory mediators and help to stabilize shock, a potentially fatal drop in blood pressure, in a wide range of patients. A recent 2019 meta-analysis, found that approximately 10% of ICU patients have septic shock at admission and an additional 8% of patients admitted to the ICU develop septic shock at some point in their hospital stay, with a high mortality of 38%. CytoSorb is being used around the world as a treatment of shock and we are conducting the PROCYSS RCT to formally evaluate CytoSorb as a treatment of this common and major unmet medical need.
Liver disease: In the treatment of acute liver disease, CytoSorb outperforms the market leading MARS® platform (Baxter) in the in vitro removal of many liver toxins, but has the added benefit of removing cytokines and inflammatory mediators, while being much easier to use. In real-world practice, CytoSorb has replaced MARS at many accounts. One in 11 people worldwide have chronic liver disease that may deteriorate and require hospitalization and blood purification. Through our Liver/Kidney division, we aim to drive CytoSorb as a therapy of choice in these patients.
Lung injury: Our U.S. CTC registry highlights the high survival of critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) treated with CytoSorb and ECMO under FDA Emergency Use Authorization. We believe these data demonstrate a therapeutic strategy of “enhanced lung rest” using the combined therapies that can be extrapolated to the treatment of ARDS in non-COVID patients, a very large market.
Longer-term growth drivers
• Stand-alone blood pump business model: There are many applications where a simple-to-use, low-cost hemoperfusion pump is adequate to implement our CytoSorb blood purification technology. This approach enables our customers to deliver CytoSorb without the complexity of a full-scale dialysis or continuous renal replacement therapy (CRRT) machine, without the need for a dialysis technician, and in clinical situations where the patient has not developed kidney failure. By improving access to care and simplifying treatment with CytoSorb in the ICU, we are potentially enabling more frequent and earlier use on more patients while supporting new “hospital-wide” applications in the emergency room, surgery suites, and elsewhere. CytoSorbents has partnered with a major international dialysis company to distribute a high-quality hemoperfusion machine and accessories, and to provide field support to customers in Germany, Austria, and Luxembourg, and are currently in the midst of a pilot launch. While early, the initial results and feedback from this pilot have been promising. Pending continued success, we plan a broader rollout in these countries, and may pursue expansion of the program to more countries in the future. We believe this can be a potentially important supplementary business model going forward that can significantly expand our total addressable markets and contribute meaningfully to CytoSorb sales growth.
• Expansion of direct sales territories: Although opening new countries with a direct sales force requires time, cost, and resources, it also allows us to directly lead the effort, drive results, and benefit from more profitable sales. With the announcement of expansion of direct sales into the U.K. and Ireland, we now sell direct in two of the E.U.’s Big 5 Economies - Germany and the U.K. – and a total of 15 countries direct overall, while working with distributors or partners in the other three Big 5 Economies: France, Italy, and Spain.
• Investment in important clinical studies in shock, liver failure, cardiac surgery, ATR, etc: We are committed to funding Company-sponsored studies, such as the STAR-T, STAR-D, and PROCYSS RCTs, in key areas that we believe will drive international adoption and usage of our technologies, with the goal of becoming a standard of care for those applications (See “Clinical Studies and Data Publications Update” below).
Dr. Chan concluded, “We firmly believe we are a solidly financed company with a robust strategic and tactical plan that positions us well for both near-term and long-term success once the effects of the pandemic abate. Although we know it has been challenging, we thank you for your understanding and continued support.”
Clinical Studies and Data Publications Update
Cardiac Surgery
• U.S. STAR-T pivotal RCT: Enrollment and site activation continues to progress. Barring the potential of another surge in U.S. COVID cases, we expect the study to reach its first scheduled milestone of 33% patient enrollment that will trigger the first Data Safety Monitoring Board (DSMB) meeting this summer, with overall study enrollment to be complete in the first quarter of 2023.
• U.S. STAR-D pivotal RCT: Site activation is ongoing with the first patient enrolled in April 2022. Pending the continuing uncertainty from the ongoing COVID-19 pandemic, we expect the study to complete enrollment in 12-18 months.
• International Safe and Timely Antithrombotic Removal (STAR) Registry continues to actively enroll patients in the U.K., Germany, and Austria, with expansion into additional EU countries before the end of 2022.
• Recent scientific publications highlight CytoSorb use in cardiac surgery for antithrombotic removal include in the Annals of Thoracic and Cardiovascular Surgery, Expert Review of Cardiovascular Therapy, Journal of Cardiothoracic and Vascular Anesthesia, and in endocarditis in the Journal of Cardiothoracic and Vascular Anesthesia.
Critical Care
• CytoSorb Therapy in COVID-19 (CTC) Registry: New data will be presented at the EuroELSO conference this week (see “Operational Highlights” above). The CTC Registry has completed enrollment at 100 patients and the final results will be presented at an upcoming international conference and submitted for publication.
• The German PROCYSS Refractory Septic Shock RCT: The study continues to actively enroll at multiple sites. The speed of enrollment remains uncertain due to COVID-19, however, we still expect to achieve the next important milestone of the interim analysis after 50% enrollment in 2023.
• The German Hep-On-Fire multicenter, single-arm trial in acute liver failure due to alcoholic hepatitis: We continue to expect that the first patient will be enrolled this quarter and that the study will complete enrollment in 2023.
• The International COSMOS Registry: Designed to capture ongoing, real-world outcomes using CytoSorb in critical care, the Registry is undergoing start-up activities and remains scheduled to begin enrollment this quarter with the goal of being active in multiple countries in 2023.
• Many peer-reviewed publications of new studies on sepsis in The International Journal of Artificial Organs and in sepsis-associated acute kidney injury in Blood Purification, as well as in acute pancreatitis in Artificial Organs, and wound healing following severe burn injury in Frontiers in Surgery. Finally, cytokine reduction using CytoSorb and the successful transplant of donated kidneys and livers from deceased donors was detailed in the International Journal of Artificial Organs.
Results of Operations for the quarter ended March 31, 2022 compared to the quarter ended March 31, 2021
Revenues
Total revenue, including product revenue and grant income, for the first quarter of 2022 was $8.7 million, down 18% from $10.6 million in the first quarter of 2021. Product sales in the first quarter of 2022 were $7.9 million, down 22% from $10.1 million in the first quarter of 2021 due to a decrease in direct sales, primarily from lower sales in Germany due to COVID-19 pandemic market conditions, as well as the impact of the decrease in the average exchange rate of the Euro to the U.S. dollar, which negatively impacted first quarter 2022 product sales by approximately $0.6 million. Due to a surge in COVID-19 case in the first quarter of 2022, many hospitals throughout Germany either maintained or reinstituted restrictions such as visitation rights to non-essential visitors. However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring ICU care, and death have been comparatively very low. This is being partly attributed to high rates of vaccinations that are associated with reduced severity of illness, reduced need for hospitalization, and risk of death. These factors led to a decrease in both COVID-19 and core non-COVID-19 CytoSorb sales in Germany. In aggregate, COVID-19 related sales in the first quarter of 2021 were estimated to be $0.3 million, compared to $1.8 million in the first quarter of 2021. Core, non-COVID-19 sales declined 9% from $8.3 million in the first quarter of 2021 to $7.6 million in the first quarter of 2022.
Cost of Revenues
Cost of revenue for the first quarter of 2022 was $2.3 million compared to $2.8 million for the first quarter of 2021. Product gross margins were approximately 80% for the first quarter of 2022, compared to approximately 77% for the first quarter of 2021, due mainly to the impact of non-recurring costs of approximately $0.7 million in the first quarter of 2021 related to prior year tariffs following an audit by the German Customs Authorities that did not recur in 2022.
Operating Expenses
Operating expenses for the first quarter of 2022 amounted to $14.2 million, a 33% increase from $10.7 million for the first quarter of 2021. Research and development expenses increased from $2.3 million in the first quarter of 2021 to $4.2 million in the first quarter of 2022 due primarily to an increase in clinical trial and related costs, rent expense on our new facility and other R&D costs. Selling, General & Administrative (SG&A) expenses increased 19% to $9.2 million in the first quarter of 2022 from $7.7 million in the prior year period due primarily to an increase in salaries, commissions, and related costs of $0.9 million, an increase in occupancy costs related to rent on our new facility in Princeton, NJ of $0.4 million, and an increase in sales and marketing costs, which include advertising and conference attendance of approximately $0.3 million, among other items. These SG&A expense increases were partially offset by lower non-cash restricted stock expense of $0.3 million, among other decreased expenses included within SG&A. Legal, financial, and other consulting expense increased from $0.7 million in the first quarter of 2021 to $0.8 million in the first quarter of 2022.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the private and public placement of our debt and equity securities. At March 31, 2022, we had current assets of approximately $55.9 million including unrestricted cash on hand of approximately $43.0 million and had current liabilities of approximately $14.7 million. As of March 31, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which is still available. In addition, we have $15 million of debt availability, providing financial flexibility, if needed. In April of 2022, we received approximately $740,000 in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.
We believe that we have sufficient cash to fund the Company’s operations beyond twelve months from issuance of the financial statements for the quarter ending March 31, 2022.
Revision of 2022 Outlook Guidance
The macro environment in which we operate remains difficult to predict given the complex drivers of our business, the global nature of our operations, and external factors such as the COVID-19 pandemic, the Russia-Ukraine war, inflation, currency exchange volatility, and other factors that are not in our direct control.
As evidence of this, since our prior guidance on March 8, 2022, where we anticipated growth of 20% or more in 2022 core product sales, Germany has since suffered a major surge in new COVID-19 cases, driven by the Omicron BA.2 variant. Although infection rates are now falling, we believe this has delayed the recovery of German hospitals and our German business. Given the importance of Germany to our financial results, and given that we see some Q1 sales trends carrying over to Q2 2022 (although this may change), we are revising our guidance to the following:
We expect COVID-19 cases and hospitalizations worldwide to continue to decline and expect to reach a more normalized operating environment as the year progresses. Because of this, we expect continued and progressive improvement in our underlying core non-COVID-19 business and expect growth in 2022 of core product sales on a constant currency basis. However, due to our limited visibility, we are removing specific growth targets with plans to revisit this later in the year. This expectation assumes:
• A gradual recovery of normalized hospital activity and sales access in Germany and other key countries
• No major economic slowdowns or major surges in COVID-19 infections caused by new COVID-19 variants
• Little to no contribution to sales from Russia and neighboring countries that might be impacted by the war. In 2021, sales from these geographies represented less than 4% of total product sales
• No escalation of the Russia-Ukraine war to other countries
• Limited COVID-19 related product sales in 2022 due to high rates of vaccination and natural immunity that have reduced the severity of COVID-19 illness and need for hospitalization and ICU care, and with it the use of CytoSorb in these patients.
For additional information, please see the Company’s Form 10-Q for the period ended March 31, 2022, filed today with the SEC on http://www.sec.gov.
Conference Call
The company will conduct its first quarter 2022 results call today at 4:30 p.m. Eastern time.
Conference Call Details:
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13728663
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: https://viavid.webcasts.com/starthere.jsp?ei=1541445&tp_key=979468cd12
An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at http://cytosorbents.com/investor-relations/financial-results/.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 170,000 cumulative CytoSorb devices have been utilized as of March 31, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/87997930/cytosorbents-reports-first-quarter-2022-results-an
Should be viewed positively by the market. Fingers crossed.
NEWS -- CytoSorbents Awarded Preferred Supplier Agreement with Asklepios, One of the Largest Private Hospital Operators in Germany
MONMOUTH JUNCTION, N.J., May 2, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced that the Company has been awarded a new preferred supplier agreement for CytoSorb® with the Asklepios Group (Asklepios), one of the largest private hospital operators in Germany, following the majority acquisition of RHÖN-KLINIKUM AG in 2020.
CytoSorbents has entered into a 3-year preferred supplier agreement with Asklepios, making CytoSorb available without restrictions to all of the approximate 170 healthcare facilities across 14 states throughout Germany that Asklepios operates. This includes Asklepios Klinik St. Georg in Hamburg, Germany, which pioneered the use of CytoSorb to remove antithrombotic drugs during cardiothoracic surgery, and is well-known for their seminal publication on CytoSorb use for this application during emergency cardiac surgery in patients at high risk of bleeding.
Dr. Christian Steiner, Executive Vice President, Sales and Marketing of CytoSorbents stated, "We are excited to announce this agreement with Asklepios, as we are now their preferred supplier of hemoadsorption technology. With this new agreement, CytoSorbents now has preferred supplier agreements with the three largest hospital chains in Germany, providing an opportunity to further grow our business. These privately owned hospital chains are always seeking value-added therapies that provide both clinical and economic benefit to ensure the highest quality medical care for their patients while supporting profitable operations. I am convinced CytoSorb is helping these hospital chains achieve both objectives."
About Asklepios Group
Asklepios was established in 1985 and is now a leading private operator of hospitals in Germany. Asklepios' business activities have always been aimed at providing future-oriented medicine for patients based on the highest quality standards. Asklepios aspires to shape the future of medicine. One key to this lies also in digitalization. The Asklepios vision of a completely integrated digital healthcare group is summed up with the term "Digital HealthyNear". The Group currently has around 170 healthcare facilities throughout Germany represented in 14 German federal states functioning as a nationwide network for holistic healthcare provision. These include acute care hospitals of all different care levels, university hospitals, specialist hospitals, prevention and aftercare, rehabilitation clinics and medical centers. In the 2021 financial year over 3.5 million patients were treated at the Asklepios Group's facilities. The company has more than 67,000 employees. For more information consult https://www.asklepios.com.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 162,000 cumulative CytoSorb devices have been utilized as of December 31, 2021. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
Please Click to Follow Us on Facebook and Twitter
Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
mailto://tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-awarded-preferred-supplier-agreement-with-asklepios-one-of-the-largest-private-hospital-operators-in-germany-301536980.html
SOURCE CytoSorbents Corporation
I smell a change of forum direction and purpose. I have yet to see this talked down the way it currently is. My gut tells me that the entire filtration group is set to become of interest to a large number of people. If just one little company that is uber advanced makes head way with the FDA, then all the other players will join the party. I might suggest that other companies are preparing for the upcoming interest. Why would anyone place a large of amount of money into this one anyway? I have never seen any significant proof of efficacy. In layman terms, data from a proper RCT arrangement has never been attached to anything I have seen here. By all means, if you have such proof or data to share please do. It can only be of help to all shareholders. Wishing you all good luck and remember you are all winners in your own special way!
We’d probably be a lot happier if the glass was indeed only half empty, but at the moment it’s much less than that. Your unbridled enthusiasm is commendable. To put it in perspective can you give us a ballpark figure regarding your total investment here (not current value) in dollar terms; hundreds, thousands, tens of thousands, more? If I had, say $2k invested, I might be equally nonchalant. Set us straight please. BTW please don’t take his as a personal attack-it’s not. Just trying to understand how folks can defend this company and their abysmal performance.
Given our timelines, I think we need a rabbit so to speak. We need a runner or a trend setter. I'd like to see a company show some real positive sepsis results all the back of a theragnostic approach with the use of precision medicines. I sure hope it is us as I know some diagnostic companies are working the cytokine angle in a big way. Hearing more and more about covid leading to sepsis. In some circles it is believed that endotoxin is present in about 75% of those with severe covid. It sure does scream for our sorb XL product. I've heard it is amazing! Even if it is still pre-clinical. Great luck to each and every handle that tells the story here. You are all winners!
Bio, I think you are genuine and, as such, I don't want to get into it with you. I'm not OK with what's happening here but I'll be right there with you if it ever turns around. Actually, I hope you're right.
Fantomphan, the glass is always half empty isn't it?
One? One patient? All the new hires and recall we dropped everything else to "concentrate" on the job at hand. CONCENTRATE HARDER or better yet SELL THE COMPANY. And I'm not a short, I'm a drowning long, a furious drowning long. WHERE IS THIS BOARD OF DIRECTORS?????
Does it make you feel good to sarcastically poke investors that have lost money? Is it because you have lost a lot yourself? Hurt people -> hurt people. It’s time to move on and make space to heal and recover, rather than trying to hurt others.
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